Step into Connection Cove—a relaxed space designed for casual chats and low-pressure networking. Come as you are; we’ve got conversation starters and ideas to make meeting others feel natural.
When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.
Workshops are NOT included with Full Conference registration and require a separate fee.
Are you fully prepared for a U.S. Food and Drug Administration (FDA) inspection? Inspections can be high-stakes events that bring stress, potential delays, and reputational risk if not managed effectively. This comprehensive full-day workshop is designed to help quality, regulatory, and research professionals approach inspections with confidence, clarity, and a concrete plan.
Moving beyond generic advice, the session delivers a structured, actionable framework—your blueprint for achieving and sustaining inspection readiness. Participants will learn how to build a proactive inspection strategy, master pre-inspection preparation, assemble and train an effective readiness team, and navigate inspection day with assurance.
The workshop emphasizes practical, real-world tactics supported by examples and interactive discussions. Attendees will leave equipped with proven tools and a step-by-step approach to strengthen their organization’s inspection readiness, reduce risk, and maintain compliance—transforming a daunting process into a manageable, even strategic, opportunity for operational excellence.
By the end of this workshop, attendees will be able to:
Explain the purpose, process, and implications of FDA inspections
Develop a proactive inspection readiness strategy
Implement effective pre‑inspection preparation practices
Assemble, train, and manage an inspection readiness team
Navigate inspection day with confidence
Apply practical tools, templates, and real‑world tactics
CEUs: 5.50 ACRP
Trainers:
Christina Brennan, MD, MBA, FACRP, Senior Vice President, Northwell
Annie Carter, MBA, CRA, ACRP-CP, Founder & Principal Consultant, Ascend Research Consulting, LLC
Workshops are NOT included with Full Conference registration and require a separate fee.
Patient recruitment remains one of the toughest challenges in clinical research, despite years of innovation and investment. While sponsors and CROs often provide recruitment solutions, the real work of identifying, engaging, and supporting patients happens at the site and community level.
This interactive workshop takes a practical, real-world look at today’s recruitment landscape. Attendees will first gain an overview of sponsor and CRO expectations, the resources they provide, and how sites can align with them. The focus then shifts to actionable strategies sites can implement immediately—emphasizing the human touch required to build trust, particularly with diverse populations.
The session also highlights emerging methods that leverage technology and data, including artificial intelligence, to strengthen traditional approaches. Participants will leave with insights into the vendor landscape, practical tools for community-level engagement, and a clearer understanding of how to integrate both human-centered and data-driven strategies for better recruitment outcomes.
By the end of this workshop, attendees will be able to:
Identify patient segments based on motivation for study participation and define tailored strategies for communication
Describe the scope of methods available for patient recruitment and their associated strengths and limitations
Apply practical, community-level recruitment strategies
Evaluate the patient recruitment vendor landscape
Discuss best practices for interacting with CROs and Sponsors
CEUs: 5.50 ACRP
Trainers:
Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen
Ashley Moultrie, CCRP, Associate Director, Clinical Trial Diversity, Syneos Health
Related Blog Content:
Workshops are NOT included with Full Conference registration and require a separate fee.
Whether you’re leading your first project or stepping up as a solo project manager, this workshop equips you with the skills and tools to succeed. In this interactive session, participants explore essential project management competencies for clinical research—communication, conflict resolution, critical thinking, negotiation, emotional intelligence, time management, and budgeting.
Working through a Phase II trial scenario, attendees examine the project manager’s role from both the site and sponsor/CRO perspectives. The session covers how to create and manage core project tools—project plans, timelines, budgets, RACI charts (responsible, accountable, consulted, informed), risk management plans, communication plans, and resourcing plans.
Participants collaborate in site- and sponsor/CRO-based teams, practicing how to adapt, problem-solve, and revise plans when challenges arise. They will leave with practical, hands-on experience and a toolkit to lead projects confidently—driving efficiency, fostering collaboration, and making a measurable impact in clinical research project delivery.
By the end of this workshop, attendees will be able to:
Apply essential project management competencies in clinical research settings
Differentiate the project manager’s role across site, sponsor, and CRO environments
Utilize practical tools for planning, scheduling, risk management, and budgeting
Strengthen leadership, communication, conflict management, and negotiation skills
Increase confidence in leading and managing clinical research projects
CEUs: 5.50 ACRP
Trainers:
Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.
Jennifer McLeland, PhD, CCRC, ACRP-PM, RPSGT, Manager, Division of Clinical Research, Washington University School of Medicine
Related Blog Content:
Workshops are NOT included with Full Conference registration and require a separate fee.
Since ICH E6(R3) was finalized, the industry has recognized that implementation goes beyond updating SOPs. It requires new ways of working, proportionate risk-based approaches, and a culture that prioritizes quality and critical thinking. This interactive workshop builds on the momentum of ACRP’s “Crack the Code” webinar, diving into the realities of R3 implementation.
Through the “Top 10 Lessons,” we’ll examine challenges and successes—embedding Quality by Design in protocol development and site operations, overseeing service providers, making data governance actionable, and defining what qualifies as an “important” protocol deviation.
Lessons will be brought to life with concise teaching segments, case studies, and interactive activities. Participants will practice applying these lessons to realistic scenarios, discuss solutions with peers, and leave with practical tools that support judgment and decision-making in their own studies.
At the core of the workshop is change management, engaging stakeholders, equipping teams with the right tools, and empowering people to embrace new ways of working.
By the end of this workshop, attendees will be able to:
Describe the 10 most common lessons emerging from R3 implementation
Recognize where organizations over-engineer or under-apply R3 principles
Apply R3 expectations to:
Protocol design
Oversight and roles
Data governance
Deviations and inspection readiness
Identify one concrete action to improve implementation in their organization
CEUs: 5.50 ACRP
Trainer:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates
Related Resources:
As the proud local chapters, the four ACRP Florida Chapters are excited to welcome ACRP 2026 attendees on Friday, April 24! Stop by their welcome table near Registration for fun giveaways and to learn about upcoming chapter activities.
Join us for a First-Time Attendee Mixer, where you'll have the chance to connect with fellow newcomers and seasoned attendees. Get tips to make the most of your conference experience.
An RSVP is required to attend. Please complete this form if you plan to join us.
Take time to learn about our poster presentations, ask questions, and engage directly with their work. Attendees can also vote for their top three poster presentations in two categories: student and non-student.
Winners will be announced Sunday at 5:30 PM at the Expo Hall Main Stage.
Kick off ACRP 2026 in style! Join us in the Expo Hall for tasty bites, refreshments, lively connections (and a few surprises!) as we celebrate what’s next. It’s the perfect way to mix, mingle, and set the tone for an unforgettable conference.
Have a complimentary headshot taken to build professional credibility and make a great impression.
The ACRP Florida Chapters will host a reception at ACRP 2026 to celebrate their members and network with local attendees. This event is invite-only. If you would like to attend, please contact chapters@acrpnet.org.
Connect with the ACRP and Academy Boards of Trustees, Committees and Council members, Fellows, Certification Milestone Recipients, and other key supporters at this reception to thank you for your contributions to the organization.
Start ACRP 2026 with a relaxed, candid dinner in a smaller, focused setting designed for real conversation.
This dinner is for the people running studies day to day: coordinators and site teams balancing protocols, study participants, source documents, and the constant pressure to catch every detail.
Join a small group of site professionals to share experiences, compare approaches, and hear how others are working through the realities of the job.
Seats are limited. Request to attend here. Confirmed guests will receive a follow-up with details.
Join us for an invigorating morning yoga practice designed to awaken both body and mind. This dynamic class synchronizes breath with movement, guiding participants through a smooth, flowing sequence of postures. Emphasizing seamless transitions, the practice cultivates a sense of fluidity, balance, and connection—helping you arrive fully present, centered, and ready to engage in the day ahead.
Let us know if you plan on attending this vinyasa yoga session by filling out the RSVP form. Space is limited to 25 attendees.
Find your calm in the Zen Den—a quiet retreat where you can unwind, reset, and take a breather from the hustle of the conference. Color your sketchbot, relax with mindful activities, or simply enjoy a peaceful moment to yourself.
Step into Connection Cove—a relaxed space designed for casual chats and low-pressure networking. Come as you are; we’ve got conversation starters and ideas to make meeting others feel natural.
When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.
Have a complimentary headshot taken to build professional credibility and make a great impression.
Start your day in the Expo Hall with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.
Signature Series Session
For years, the clinical research industry has pursued transformative changes—seeking smarter trials, more efficient processes, and improved patient outcomes. Today, those long-awaited advancements are no longer aspirational—they're happening. From decentralized trials and AI-driven insights to streamlined protocols and enhanced patient engagement, the future of clinical research is unfolding in real time.
Join ACRP and leading voices from across the clinical research ecosystem for a dynamic discussion on how we’re meeting this pivotal moment—and shaping what comes next.
Key Topics:
Emerging approaches that are redefining trial design and execution
The promise and pressure of integrating new technologies
What excites stakeholders today—and what they envision for tomorrow
How collaboration and innovation are solving today’s toughest challenges
From site professionals to sponsors and tech innovators, this session will deliver practical insights and forward-thinking strategies to help every stakeholder across the clinical research enterprise to advance with confidence—because what’s next is happening now.
At the end of this session, attendees will be able to:
Describe current and emerging trends shaping the future of clinical research
Assess the gap between today’s clinical research practice and the future
Identify which practices to change and which new ones to adopt to advance clinical trials
Apply the panel’s recommendations to their own practice
CEU: 1.00 ACRP
Speakers:
Barbara Bierer, Faculty Director, Harvard Medical School
Kevin Bugin, Associate Vice President of Global Regulatory Policy and Intelligence, Amgen
Rob DiCicco, Vice President of Portfolio Management, TransCelerate Biopharma Inc.
Morgan Hanger, Executive Director, Clinical Trials Transformation Initiative
Jennifer Byrne, Chief Executive Officer and Board Director, Javara (Moderator)
Perk up with a shot of caffeine and a splash of conversation—don’t miss this 15-minute recharge in the Expo Hall!
This session explores a real-world case study from an interventional oncology trial to demonstrate how informed consent can be ethically and systematically optimized for vulnerable participants with impaired decision-making capacity. Attendees will examine how regulatory requirements and institutional safeguards can be integrated into a practical framework that ensures participant protection while supporting trial enrollment. Through a step-by-step analysis, we will cover patient eligibility verification, capacity assessment, legally authorized representatives, and documentation practices. The session offers a reproducible and proactive framework for how early planning, use of validated tools, and adherence to institutional review board guidance can support ethical trial conduct involving vulnerable populations.
CEU: 1.00 ACRP
Speaker:
Elena Alferova, Clinical Research Regulatory Coordinator II, UCSD Moores Cancer Center
Watch a Sneak Peek into the Session Content:
Artificial Intelligence (AI) is no longer a futuristic concept in clinical trials, it’s an emerging reality with real-world impact across design, recruitment, operations, and data analysis. This session presents insights from a multi-stakeholder working group exploring how AI is being applied in practice, what responsible use looks like, and what collective standards are needed to ensure adoption accelerates rather than fragments progress. Through interactive discussion and scenario-based exploration, participants will examine proposed practical frameworks for AI governance, definitions of responsible use, and baseline metrics for measuring AI’s effectiveness. The session will also outline regulatory engagement strategies and explore key global differences in AI oversight. Attendees will leave with tools to guide internal conversations, assess vendor claims, and contribute to shared industry alignment on AI in trials.
CEU: 1.00 ACRP
Speakers:
Andrea Bastek, Ph.D., VP of Market Strategy, Florence Healthcare
Victor Chen, Principal, The CK Clinical Group
Heather Manley, MS, LPC, Senior Site Director, JCCT
Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.
CEU: 1.00 ACRP
Speakers:
Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
Jess Thompson, CEO, Clinical Research Pro
Jami Walker, Clinical Operations and Management, Mead Johnson
Watch a Sneak Peek into the Session Content:
Time to activation remains one of the most critical and challenging determinants of site performance in clinical research. Delays in startup don’t just slow enrollment; they impact investigator engagement, sponsor confidence, and long-term competitiveness. This session explores how organizational models, centralized, decentralized, and hybrid, shape activation timelines in real-world settings.
Drawing on practical examples, we’ll examine why activation delays rarely stem from a single step, but from fragmented workflows, limited visibility, and unclear accountability across feasibility, budgeting, contracting, and review processes. Participants will learn when centralization can drive clarity and consistency, where decentralization adds value, and how high-performing organizations intentionally design hybrid models to balance efficiency with local expertise.
Attendees will leave with a clearer understanding of the activation critical path, the role of parallel work, and the metrics that truly matter when building sustainable speed into study startup.
This session does not provide ACRP Contact Hours.
Speakers:
Shannon Chism, Education & Research Consulting Sr. Director, Huron Consulting Group
Mindy Muenich, Education & Research Sr. Director, Huron
Federally Qualified Health Centers (FQHCs) are nonprofit organizations governed by patients that provide high-quality, comprehensive healthcare to medically underserved populations across the United States, regardless of income or insurance coverage. In 2023, FQHCs served 32.5 million patients, with 63% identifying as people of color. In North Carolina specifically, FQHCs serve more than 750,000 patients annually, with more than 60% of them being people of color. Despite this broad reach and impact, FQHCs remain an underutilized resource in clinical research. This session will explore how FQHCs can serve as decentralized clinical trial sites to expand access and address long-standing disparities in trial participation. The session will highlight insights from surveys and questionnaires completed by patients and FQHC care teams, share best practices for integrating clinical trials, and discuss the necessary infrastructure to support research within FQHCs.
CEU: 1.00 ACRP
Speakers:
Rebecca Hayes, MD, MEHP, Director of Research, North Carolina Community Health Center Association
Korrey Monroe, MPH, Research Program Manager, North Carolina Community Health Center Association
Mayra Overstreet Galeano, Chief Medical Officer, Community Faculty, Adjunct Assistant Professor, MedNorth Health Center, Novant Health, University of North Carolina at Chapel Hill
Peter Shin, PhD, MPH, Chief Science Officer, National Association of Community Health Centers
Watch a Sneak Peek into the Session Content:
Whether you're early in your career or a seasoned professional, it’s easy to confuse “doing good work” with “communicating your value.” This session offers practical tools to help you tell your professional story with clarity and purpose—on paper, online, or in conversation. Through guided reflection, real-world examples, and structured templates, you will learn to draft an authentic elevator pitch, apply the STAR (Situation, Task, Action, Result) method to describe outcomes, translate daily work into impactful résumé or LinkedIn content, and outline a focused 30-day communication plan with practical actions to build visibility and confidence. Beyond the job-seeking context, the focus is on ongoing visibility and confidence—whether you are looking to grow, pivot, or lead from where you are. Advancement isn’t just about upward mobility—it’s about alignment with your goals. This session delivers usable tools to help you own your narrative and support career development in any direction.
CEU: 1.00 ACRP
Speakers:
Alissa Mun, Health Scientist Policy Analyst, U.S. Food & Drug Administration
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
As clinical research grow more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startup, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive.
CEU: 1.00 ACRP
Speakers:
Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Karen Lane, CCRP, Assistant Professor of Neurology, Johns Hopkins University Deputy Director, BIOS Clinical Trials Coordinating Center Director, Multicenter Study Operations Training Program, ICTR MPI, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Watch a Sneak Peek into the Session Content:
Transform your workplace culture through proven strategies that build genuine employee engagement, trust, and accountability. This session focuses on creating a thriving organizational environment where employees feel valued, connected, and motivated to contribute their best work. Participants will learn to establish trust as the foundation of engagement through transparency and consistent leadership behaviors. The session features the innovative ALIGN method for collaborative goal setting, enabling teams to create shared objectives that drive organizational success. Discover how to shift from traditional performance reviews to growth-focused evaluation conversations that inspire development rather than judgment. Learn to implement positive accountability systems that support employees while building trust. Key topics include positive workplace habits, open communication channels, transparent progress tracking, and sustainable cultural change through continuous feedback and recognition. Attendees will leave with practical frameworks and actionable strategies to immediately transform their workplace culture.
CEU: 1.00 ACRP
Speaker:
Leslie Pimentel Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
Watch a Sneak Peek into the Session Content:
Too few research organizations (e.g., sponsors and sites) have access to the large and diverse populations that primary care organizations (PCOs) and their healthcare professionals serve. This session will bring forth the results and easy-to-use, action-oriented tactics from the first-of-its-kind “Research in Primary Care Action Roundtable,” which included participants from PCOs, study sponsors, and study sites. PCOs are a healthcare entity focused on delivering first-contact, comprehensive, and continuous care to individuals and families across all ages, genders, and health conditions. They care for more than 100 million people in the United States, yet clinical trial access and participation through them continue to be seen at minimal levels. A shared vision is to build a movement to make clinical trials mainstream in support of healthcare’s pivot toward value-based care, and to provide research organizations with access to large and diverse populations leading to more efficient, representative, and accelerated study enrollment.
CEU: 1.00 ACRP
Speakers:
Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech
Osa Eisele, MD, MPH, Executive Director and Head of Representation in Clinical Research, Amgen
Pete Fronte, MBA, President & CEO, Altura
Rakesh Patel, MD, MBA, FACHE, CPE, CEO, Neighborhood Healthcare
Watch a Sneak Peek into the Session Content:
Patient recruitment remains a persistent challenge for sites in clinical trials. This presentation explores promising solutions and collaborative strategies to transform recruitment outcomes. Panelists will discuss how they are successfully leveraging patient recruitment solutions, financial and operational barriers, and how patient advocacy engagement can bridge the gap between sponsors, CROs, and patient populations—particularly in oncology and rare disease studies.
Key Takeaways:
Understand the need for sponsors and CROs to work in partnership with investigative sites to improve recruitment and retention outcomes in clinical trials
Learn why sites face out-of-pocket expenses for recruitment solutions and discover collaborative approaches with sponsors, CROs, and vendors to reduce financial burden and create sustainable reimbursement models
Explore how patient advocacy engagement bridges the gap between sites and patient populations and discover practical solutions for sponsors and CROs to connect sites with advocacy resources
This session does not provide ACRP Contact Hours.
Speaker:
Leslie Ives, Senior Director, Patient Recruitment, Parexel
Engaging vulnerable populations in research requires careful consideration of ethical and practical challenges. Researchers must prioritize participants' safety, privacy, and well-being while ensuring the research is meaningful and impactful for the community. This presentation will highlight real-world experiences, challenges, and practical solutions for involving vulnerable populations in research during trying times such as those we face now.
It's important to emphasize that additional protections should not deter researchers from involving these groups. Instead, such safeguards enable ethical inclusion, ensuring that individuals who may benefit most from research are not systematically excluded due to perceived risks or complexities.
CEU: 1.00 ACRP
Speaker:
Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center
Related Blog Content
Watch a Sneak Peek into the Session Content:
How does a site know that a sponsor's medical device and study design will generate appropriate scientific evidence to justify or require a clinical trial? Sites may already be familiar with the sponsor and investigator responsibilities for Investigational Device Exemption (IDE) studies outlined in 21 CFR 812 of the Code of Federal Regulations, but this session will provide a tutorial on the regulatory expectations for IDE application submission or a non-significant risk (NSR) determination before initiating device clinical trials. The content will cover IDE applications and the documents that will be reviewed by the U.S. Food and Drug Administration before approving an IDE and how an NSR determination translates to abbreviated 21 CFR 812 requirements. Also discussed will be design controls to ensure a medical device is clinically ready for a clinical trial and how they still apply to NSR device studies including in vitro diagnostic products.
CEU: 1.00 ACRP
Speaker:
Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
As the University of Alabama at Birmingham's Clinical Research Support Enterprise (CReSt) expanded, traditional systems proved insufficient for managing the growing complexity of clinical trial operations. Determining trial costs became a focus, with a goal of implementing no-cost, scalable solutions that improved visibility across the trial lifecycle, empowered staff, and could be replicated by other institutions. The CReSt unit adopted a suite of open-source tools to develop platforms for managing such core trial functions as study startup, enrollment tracking, subject reimbursements, and automated reporting. These tools were created entirely by clinical research administrators without the support of an information technology team or professional developers. Crucially, generative artificial intelligence (AI) tools were used to build, debug, and refine these systems. These tools accelerated development and lowered the technical barrier for non-programmers to build impactful solutions.
CEU: 1.00 ACRP
Speaker:
Meredith Fitz-Gerald, RN, MSN, Clinical Research Support Enterprise Director - Education and Clinical Outreach, The University of Alabama at Birmingham
Watch a Sneak Peek into the Session Content:
Bringing a novel implantable device from concept to human trials is daunting—doing it entirely within an academic setting, without commercial sponsorship, is almost unheard of. Our team successfully navigated the full translational pipeline: developing the device and treatment protocol, conducting rigorous preclinical testing, securing U.S. Food and Drug Administration (FDA) Investigational Device Exemption approval, and executing an early feasibility study, ultimately culminating in a Nature publication. This session provides a practical framework for managing operational complexity in sponsor-investigator trials. We will share actionable strategies for communication, regulatory preparedness, role delineation, and risk mitigation—focusing on the tools and practices that allowed our team to proceed with confidence. For academic institutions, startups, or research teams operating at the edge of innovation, this session offers grounded, replicable strategies for moving from concept to clinic—and highlights the operational systems we would never do without.
CEU: 1.00 ACRP
Speaker:
Amy Porter, PE, MBA, Director, Texas Biomedical Device Center at the University of Texas at Dallas
Watch a Sneak Peek into the Session Content:
Step into the ACRP 2026 Video Kiosk and share your story! Celebrate a standout conference moment or reflect on how membership, certification, or the ACRP community has supported your growth as a clinical research professional. Your voice can inspire others—and it only takes a few minutes to record.
Enjoy your favorite specialty coffee and an extra afternoon boost in Booth #411.
Step into an exclusive gathering of 300 directors, managers, and executives who are shaping the future of clinical operations. Hosted in the stunning Hyatt Regency Rotunda on Saturday, April 25, this luncheon will be the ideal setting for strategic dialogue and networking at the highest level. Those who attend with a Full Conference, Saturday, and Weekend Registration will be able to confirm their participation this spring.
If your company would benefit from deep brand visibility and access to top-tier decision-makers in clinical research, please contact Bruce Bassin to learn how you can sponsor this high-profile event.
Break for lunch and discuss what’s next—connect with your community, share your top takeaways with your peers, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.
Be sure to leave time to visit at least 10 exhibitor booths to collect stamps for your Go for Prizes card!
Have a complimentary headshot taken to build professional credibility and make a great impression.
Take time to learn about our poster presentations, ask questions, and engage directly with their work. Attendees can also vote for their top three poster presentations in two categories: student and non-student.
Winners will be announced Sunday at 5:30 PM at the Expo Hall Main Stage.
This presentation will discuss the experience and process of building a quality assurance/quality improvement (QA/QI) program from the ground up following the merger of two large health systems across geographical distances. It will discuss where to begin, considerations when designing services, operationalization, the importance of including stakeholders, and lessons and pitfalls learned through real-world experiences.
CEU: 1.00 ACRP
Speakers:
Sarandeep Kaur, MS, CCRC, Research Accountability Specialist, Corewell Health
Karen Sherer, Director, Research QA/QI, Corewell Health
Laura Stuecher, RN, BSN, CCRP, QA/QI Research Specialist, Corewell Health
Watch a Sneak Peek into the Session Content:
The value of engaging non‑traditional and emerging sites is widely recognized, yet many of these sites continue to be overlooked due to a lack of prior trial experience. This creates a persistent cycle: sites struggle to build experience without access to studies, while sponsors often prioritize experience when selecting sites—ultimately limiting broader representation in clinical trials.
With funding from Roche | Genentech, Duke Clinical Research Institute, and National Medical Fellowships, and support from Continuum Clinical, ACRP and its collaborators will share preliminary findings from qualitative interviews with sponsors and non‑traditional sites. These insights highlight real‑world barriers to participation in Phase III studies. Attendees will gain practical insight into how rethinking site selection—and more intentionally engaging non‑traditional sites—can support stronger recruitment outcomes while advancing meaningful representation.
CEU: 1.00 ACRP
Speakers:
Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech
Laveina Dash, Director, Doctors in Clinical Trials Research (NMF DCTR), National Medical Fellowships
Pete Fronte, MBA, President & CEO, Altura
Karen Lipworth, Communications Strategist and Senior Medical Writer, ACRP
Kathy Mickel, Director of Membership & Programs, Society for Clinical Research Sites
Susan P. Landis, Chief Executive Officer, Association of Clinical Research Professionals (Moderator)
This session will delve into how sponsors develop effective recruitment strategies for clinical trials, emphasizing the practical impact of these tactics. Attendees will gain insights into how feedback from clinical sites is utilized by sponsors to craft creative and adaptive recruitment approaches. The session will highlight real-world examples and case studies to illustrate the success of these strategies in enhancing participant engagement and trial efficiency.
CEU: 1.00 ACRP
Speakers:
Simranjit Mehta, Recruitment Strategist, Pfizer
Nikki Thomas, Recruitment Strategist, Pfizer
Watch a Sneak Peek into the Session Content:
The clinical research workforce is facing growing challenges, especially in the recruitment and retention of research nurse coordinators. This session will highlight an innovative collaboration between a clinical research team and a bachelor of science in nursing program aimed at introducing nursing students to clinical research as a meaningful and dynamic career option. By engaging future nurses early in their education, this partnership helps bridge the gap between clinical care and research, building awareness, interest, and preparedness among new graduates. Attendees will hear how this model not only expands the pipeline of qualified professionals but also enhances the visibility and value of the research nurse coordinator role within healthcare. The presenters will share insights, lessons learned, and steps for developing similar collaborations with nursing schools. This forward-thinking approach has the potential to significantly strengthen the clinical research workforce and ensure a more sustainable, informed, and engaged generation of research-ready nurses.
CEU: 1.00 ACRP
Speakers:
Lauren Hasty, Clinical Research Nurse, St Jude Children's Research Hospital
Jamie Russell, Manager- Clinical Research Management, St Jude Children's Research Hospital
Related Blog Content:
Watch a Sneak Peek into the Session Content:
This dynamic session explores the complexities and opportunities of conducting clinical research outside the United States. Through real-time polling, interactive Q&A, and scenario-based reflection, attendees will gain practical insights into regulatory, cultural, and operational differences across global regions. The session will equip clinical research professionals with tools and strategies to confidently engage in multinational trials, while promoting inclusion, equity, and global collaboration.
CEU: 1.00 ACRP
Speaker:
Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy
Watch a Sneak Peek into the Session Content:
This highly interactive session will introduce participants to an innovative, multiculturally aware approach for advancing equitable and inclusive representation in clinical trials. We will share our journey in developing and piloting a novel engagement model, highlighting both the community-engaged design process and early findings from our pilot implementation. Participants will then engage in a hands-on activity that maps key inclusivity-driven strategies and frameworks from our model to their own work. By the end of the session, attendees will leave with practical, actionable tools to advance equity and racial justice in their clinical trial recruitment efforts.
CEU: 1.00 ACRP
Speakers:
Chaya Pflugeisen, MSc, MEd, Manager, Investigator Initiated Research, MultiCare Health System
Deana Williams, PhD, MPH, Research Investigator, MultiCare Health System
Watch a Sneak Peek of the Session Content:
The ACRP 2026 Conference Advisory Working Group (CAWG) works closely with ACRP staff to develop the program for the Annual Conference. Drawing on their diverse experience and real-world knowledge of the clinical research industry, CAWG members provide expert guidance on educational programming and offer detailed feedback as part of the submissions review process.
If you are interested in joining the CAWG, please complete this interest form. Several CAWG members will be at ACRP Booth #531 in the Expo Hall from 2:15 - 3:00 PM on Saturday and Sunday to share information about the Conference Advisory Working Group for ACRP 2027.
Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this afternoon networking break.
Delays in clinical trial budgeting often result not from lack of effort, but from a lack of shared understanding across stakeholders. Sites, sponsors, and contract research organizations each have different processes and constraints that create friction in this critical startup process. This session presents findings from a cross-industry working group that explored the root causes of budgeting misalignment and developed practical, stakeholder-informed strategies to close the gap. The group’s work centers on three key domains—study startup operations, budget estimation, and budget justification—and shares insights from real-world experiences across the research ecosystem. The goal is to accelerate study startup by building mutual understanding, streamlining communication, and promoting efficient negotiation. Attendees will walk away with actionable tools that can be used to upskill staff, improve cross-functional collaboration, and support an improved approach to budgeting in clinical research.
CEU: 1.00 ACRP
Speakers:
Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences
Andrea Bastek, Ph.D., VP of Market Strategy, Florence Healthcare
Heidi Castle, CCA, Director, Business Development, Mercy Research
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Artificial intelligence (AI) is revolutionizing clinical research by enhancing protocol generation, operational efficiency, and participant recruitment/engagement. Through predictive analytics and digital twins, AI streamlines protocols, optimizes inclusion criteria, and minimizes risk. AI also strengthens safety monitoring by identifying early adverse event patterns across diverse datasets, enabling proactive responses. For sponsors and sites, AI supports ongoing access to training and streamlines standard operating procedure development by analyzing past performance and recommending standardized practices. It automates data collection, reducing manual errors and accelerating timelines. In recruitment, machine learning matches ideal candidates using electronic health records and real-world data, while adaptive algorithms personalize recruiting messaging to improve enrollment rates. Together, these innovations reshape the trial landscape, making studies faster, safer, and more inclusive without compromising data integrity or participant protection. Examples reviewed include seen and unseen real-world AI impacts.
CEU: 1.00 ACRP
Speakers:
Alain Alvarez Legra, Director for Clinical Research Coordinators, Bolanos Clinical Research
Karen Lindsley, DNP, MSN, RN, CCRC, CDCES, Manager of Regulatory Knowledge and Support, Clinical and Translational Science Alliance of Georgia, Emory University
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In a rapidly evolving clinical research landscape, effective leadership is more crucial than ever for driving collaboration, innovation, and trust among academic centers, site management organizations, and technology partners. This dynamic session will introduce the “Four Cs” leadership framework—character, competence, caring, and communication—adapted for today’s complex research environment. Three seasoned leaders with varied backgrounds will share insights on how leadership philosophies must adapt to varying organizational cultures, regulatory demands, and operational realities. Attendees will explore practical strategies to cultivate leadership capacity, manage resource constraints, and prevent burnout while promoting ethical and patient-centered research. Real-world stories will illuminate challenges and solutions in building and sustaining successful collaborations among sites, sponsors, contract research organizations, and academia. The session encourages interactive discussion, equipping attendees with actionable tools to strengthen their own leadership impact and foster high-performing, resilient research partnerships.
CEU: 1.00 ACRP
Speakers:
Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health
Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Related Blog Content:
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In 2025, the U.S. Department of Health and Human Services (HHS) initiated several significant policy changes impacting how clinical trials are conducted in the U.S. This session will explore five major developments: updated informed consent standards prioritizing plain language and accessibility; new HHS-led interoperability efforts to streamline trial data exchange; clarified Internal Revenue Service guidance on taxing participant stipends; a shift from mandated diversity action plans to a voluntary reporting framework; and cross-agency modernization efforts through the HHS Clinical Trials Modernization Working Group. These changes—while intended to promote transparency and innovation—have introduced ambiguity for sites, sponsors, and contract research organizations. Attendees will gain clarity on how to operationalize these updates, navigate compliance challenges, and align processes with the evolving federal landscape in 2026 and beyond.
CEU: 1.00 ACRP
Speakers:
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Sophia McLeod, Director, Government Relations, Association of Clinical Research Organizations (ACRO)
Related Blog Content:
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings.
Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise.
CEU: 1.00 ACRP
Speaker:
David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare
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Strong collaboration between contract research organizations (CROs) and study sites is essential for reducing trial delays, improving data quality, and accelerating patient access to new therapies. This panel, designed for clinical research professionals in operations, monitoring, study startup, and site roles, explores how intentional collaboration between CROs and study sites can drive measurable improvements in operational efficiency and data quality. Panelists will share real-life case studies and practical examples that highlight strategies for streamlining study startup, reducing rework, and building trust. Attendees will gain forward-thinking insights and walk away with actionable tips, tools, and processes to strengthen site-CRO relationships and enhance trial success. Join us to explore how shifting from reactive problem-solving to proactive partnership can transform site-CRO relationships into high-impact alliances that advance research and patient care.
CEU: 1.00 ACRP
Speakers:
Elizabeth Feathers, Clinical Operations Supervisor, Study Startup, CIBMTR
Kassandra Nealon, BS, Clinical Operations Manager, CIBMTR
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Whether you’re a coordinator worried about missing a detail, a site director focused on quality, or a sponsor looking for practical ways to help ease site burden, this session is for you.
Hear directly from sites about how Peter The Protocol Reader, a practical AI assistant, is helping give time back each day. From quickly checking whether a medication is prohibited to streamlining preparation for a patient visit, Peter is helping teams work through everyday study questions faster and with less mental burden.
You’ll also hear why sponsors like Merck are embracing Peter for their sites and what sponsors require when AI is used for their studies.
Come see why hundreds of coordinators have Peter supporting their daily workflows and how you can get started.
This session does not provide ACRP Contact Hours.
Speakers:
Haitham Abulaban, MBBS, CCRC, ACRP-PM, Founder and CEO, Lakeview Institute of Clinical Research
Rupi Bancil, Senior Vice President of Global Study Operations & Global Expansion, CareAccess
Sarah Branch, Sr. Global Trial Optimization Specialist (GTOS), Merck
Gloria Calbert, Bradenton Research
Justin Yang, MD, MPH, FACRP, FACOEM, Principal Investigator, CareAccess
Artificial intelligence (AI) is transforming clinical research by streamlining patient identification, automating data capture, and enhancing imaging analysis. This session explores practical applications of AI in oncology trials, focusing on three high-impact areas: 1) patient matching and identification using advanced algorithms to accelerate enrollment and improve diversity; 2) seamless data collection through integration from electronic medical records to electronic data capture, reducing manual errors and increasing efficiency; and 3) automated imaging analysis, such as AI-driven RECIST measurements, to improve consistency and speed in response assessments. Attendees will take away actionable insights and learn from real-world examples for implementing AI solutions while addressing challenges in adoption, data quality, and regulatory considerations.
CEU: 1.00 ACRP
Speaker:
Chelsea Osterman, MD, Executive Medical Director, Tempus AI
Related Blog Content:
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The session is designed to open the door to a live reinactment of an institutional review board (IRB) meeting that includes samples of the the most sensitive and controverted decisions facing IRBs today. The purpose is to inform researchers of the inner workings and, more importantly, the often intense deliberations arising from today's clinical trial proposals and reports as the panel reconciles regulatory mandates and ethical principles with modern research conundrums. The 30-minute, mock IRB meeting will include a protocol, amendment, report of noncompliance, and continuing review followed by a 15-minute Q&A opportunity.
CEU: 1.00 ACRP
Speakers:
Claudia G. Christy, MSN, RN, CCRC, ACRP-CP, FACRP, IRB Board Member, Univo IRB
Melissa Gottke, BA, CIP, IRB Chairperson, Advarra
Amanda Higley, MS, PhD, CIP, IRB Chair Director, Advarra IRB
Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB
Deborah L. Rosenbaum, FACRP, CCRC, CCRA, ACRP-CP, ACRP-PM, Consultant, Sarrison Clinical Research, LLC
Related Blog Content:
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Clinical expertise has a clearly defined role and purpose in clinical research from randomizing treatments to managing adverse events to monitoring the overall health of participants. However, scientific expertise seems to be expected only from those who design studies, analyze final datasets, and manage the investigational products in question. This increases a sense of separation between sponsors and sites that results in clinical trial operations being considered mostly in terms of financial transactions. At the site level, a similar divide in research staff often occurs as the study coordinators understand the study mechanics and the medical clinicians understand the disease, often causing friction in operations and staff turnover. By developing a novel clinical research model, our team has addressed these gaps and witnessed improvements in staff recruitment and retention as well as decreases in detrimental protocol deviations. This model includes a clear career development pathway for clinical research professionals.
CEU: 1.00 ACRP
Speaker:
Lacey Andrews, MS, CCRC, CCRA, Lead Coordinator, Marshall University's Joan C. Edwards School of Medicine, Department of Family and Community Health
Todd Davies, PhD, Associate Director of Research, Marshall Health
The clinical research industry offers a variety of career pathways, yet many site-based professionals struggle to transition to roles within contract research organizations or sponsor settings. This session will outline the skills, experiences, and strategic positioning needed to make that leap successfully. Drawing from real-world examples, panel insights, and current hiring trends, we’ll explore how site-based coordinators, managers, and research staff can translate their operational expertise into qualifications for project management, clinical research associate, medical affairs, regulatory affairs, and other sponsor-side roles. Attendees will leave with a roadmap, tools for self-assessment, and strategies to proactively align their current responsibilities with future goals.
CEU: 1.00 ACRP
Speakers:
Tamika Harris, Clinical Operations Manager - Regulatory, Merck
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
Related Blog Content:
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This interactive presentation guides participants through applying proven project management principles across all scales of work, from organizational initiatives to everyday task management. Attendees will learn to leverage essential project management tools including strategic planning frameworks, effective scheduling techniques, Gantt chart creation and interpretation, and dependency mapping to optimize workflow and productivity. Through practical examples and hands-on exercises, participants will discover how to break down complex projects into manageable components, identify critical path dependencies, and create realistic timelines that account for resource constraints and competing priorities. The session will demonstrate how the same methodologies that drive successful large-scale initiatives can transform daily task management, reducing stress and increasing efficiency.
CEU: 1.00 ACRP
Speaker:
Leslie Pimentel Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
Related Blog Content:
Step into the ACRP 2026 Video Kiosk and share your story! Celebrate a standout conference moment or reflect on how membership, certification, or the ACRP community has supported your growth as a clinical research professional. Your voice can inspire others—and it only takes a few minutes to record.
Have a complimentary headshot taken to build professional credibility and make a great impression.
Connect with your colleagues and 50+ leading-edge organizations and suppliers helping you get better results in clinical research.
Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.
If you’ve collected stamps from 10 booths, drop off your prize card at the ACRP booth #531 and be there at 5:00 and 5:15 for your chance to win one of our high-value giveaways, including an iPad, a Breville Espresso Machine, a YETI Soft Cooler, gift cards, and more—must be present to win!
Join fellow attendees for a special party where you’ll gather with the people who’ve shaped our journey—and those who will lead its future.
All ACRP 2026 registrants are invited to attend the ACRP at 50 Anniversary Celebration, where we’ll honor five decades of advancing excellence in clinical research and the community that makes it possible.
Full conference, weekend, Saturday, and Expo only registrants are encouraged to attend.
There is not an additional registration fee.
You will not need to register in advance to reserve your spot.
Gold attire is encouraged
This is our moment to connect across generations, share stories, and celebrate our collective impact. Let’s envision the possibilities for what’s to come in the next fifty years of clinical research—together!
Find your calm in the Zen Den—a quiet retreat where you can unwind, reset, and take a breather from the hustle of the conference. Color your sketchbot, relax with mindful activities, or simply enjoy a peaceful moment to yourself.
Step into Connection Cove—a relaxed space designed for casual chats and low-pressure networking. Come as you are; we’ve got conversation starters and ideas to make meeting others feel natural.
When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.
Have a complimentary headshot taken to build professional credibility and make a great impression.
Start your day in the Expo Hall with a delicious breakfast and engaging conversations—connect with 50+ innovative organizations driving better results in clinical research.
Step into the ACRP 2026 Video Kiosk and share your story! Celebrate a standout conference moment or reflect on how membership, certification, or the ACRP community has supported your growth as a clinical research professional. Your voice can inspire others—and it only takes a few minutes to record.
Signature Series Session
Clinical research is a dynamic field shaped by the people who plan, conduct, and oversee it at every career stage. This engaging panel brings together diverse voices to share their career journeys, the leadership skills that fueled their growth, and the pivotal moments that defined their paths.
Panelists will offer insights on:
How they entered and advanced within clinical research
The leadership competencies that made the greatest impact
Lessons learned and practical advice for others shaping their careers
What keeps them motivated and passionate in an evolving field
Whether you’re just starting out or guiding the next generation, this conversation will highlight the resilience, leadership, and sense of purpose that drive long-term success. You’ll walk away with fresh perspectives, actionable guidance, and renewed inspiration to chart their own path, make meaningful contributions, and thrive in a field that is constantly evolving.
At the end of this session, attendees will be able to:
Explain leadership as a core competency in clinical research
Recognize and cultivate their own leadership style
Identify common leadership blind spots
Create their own action plan
CEU: 1.00 ACRP
Speakers:
Michelle Rowe, RN, VP, Research, HCA Healthcare
Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck
Muriel Maignan Wilkins, CEO & Founder, Paravis Partners
Susan P. Landis, Chief Executive Officer, Association of Clinical Research Professionals (Moderator)
Related Blog Content:
Perk up with a shot of caffeine and a splash of conversation—don’t miss this 15-minute recharge in the Expo Hall!
The Careers in Clinical Research (C-CLEAR) Program is an eight-week immersive summer experience designed to introduce undergraduate students to careers in oncology clinical trials. Hosted by the University of Kansas Cancer Center's Clinical Trials Office, the program provides hands-on exposure to core research functions including informed consent, protocol navigation, adverse event reporting, regulatory documentation, and data entry. Students complete Good Clinical Practice (GCP) training and gain real-world experience through shadowing across multiple departments, including time with oncologists in the Phase One Clinic. The program also emphasizes professional development through mentorship, résumé building, and final presentations to research staff. This session will present a practical and replicable model for building early-career pathways into clinical research. Attendees will receive tools, strategies, and lessons learned to support workforce training and sustainable pipeline development in academic research settings.
CEU: 1.00 ACRP
Speaker:
Joseph Hines II, MPH, Executive Director, Research Operations-Clinical Trial Office, University of Kansas Cancer Center
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In response to growing pressures from federal sponsors to demonstrate efficient research oversight, the Penn State College of Medicine undertook a strategic reorganization of clinical research monitoring and auditing services. This effort involved centralizing monitors from multiple units and realigning an auditor into our human research quality assurance office. A scalable chargeback model was developed to support this new structure, financial stewardship, and risk-based workload allocation. Attendees will learn how institutions can transition from siloed, grant-dependent quality functions to a centralized model that is both cost-recoverable and operationally sustainable. They will learn how to evaluate capacity, align oversight with risk profiles, and design a flexible fee structure based on study complexity and enrollment. The session explores how the reorganization positions the institution to adapt to the evolving expectations around indirect costs. This presentation provides a practical roadmap for modernizing research oversight by enhancing sustainability, or maximizing value from existing resources.
CEU: 1.00 ACRP
Speaker:
Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director, Clinical Trials Office, Penn State College of Medicine
Ready to take the next step in your clinical research career? Join this expert panel of ACRP Certified professionals—leaders who’ve served on the Academy Board, committees, as item writers, and more—to gain insider knowledge on achieving your certification.
They’ll share their personal journeys and practical strategies for success, from navigating the application process to preparing for the exam. Discover what to expect during eligibility review, explore testing options, and learn proven study tips that can help you earn the most reputable credentials in the clinical research industry. ACRP Certification goes beyond the letters—learn how it can be a catalyst for impact, opportunity, and career growth.
Please note that this session will not cover exam content. If you have questions regarding your individual certification journey, please talk to the staff at the ACRP booth in the Expo Hall.
This session does not provide ACRP Contact Hours.
Speakers:
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
Tiffany Taylor Mayo, MD, Associate Professor of Dermatology; Director of Dermatology Clinical Research, The University of Alabama at Birmingham
Jen Milam CAE, ICE-CCP, Certification Manager, ACRP
Robert O’Connor, CCRA, ACRP-CP, FACRP, Senior Clinical Scientist, The Procter & Gamble Company
The emergence of decentralized clinical trials (DCTs) has reshaped the way we approach execution of clinical trials requiring few or no face-to-face touchpoints with patients. A successful DCT requires a different operational infrastructure, different technology, and different personnel from a traditional clinical trial. This session offers a practical, end-to-end toolbox for designing and operationalizing DCTs. Attendees will learn actionable strategies for protocol design that allow remote workflows and patient-centric recruitment. We will discuss common pain points that contribute to attrition in DCTs and strategies for prevention. The session will review approaches for building and leading remote teams and for leveraging technology to improve efficiency of remote work. Finally, we will discuss the role of the principal investigator, research coordinator, and data manager as they are deployed in a decentralized fashion. This talk is for those interested in launching DCTs and for those running DCTs who want to expand their capabilities.
CEU: 1.00 ACRP
Speakers:
Kimberly Lamberti, PhD, Senior Clinical and Regulatory Affairs Specialist II, Nilo Medical Consulting Group
Marianne Parrish, MPH, Clinical Project and Data Manager, Nilo Medical Consulting Group
The field of oncology clinical trials is dynamic and intricate, with continuous evolution introducing new challenges for research sites. This panel discussion features seasoned representatives from highly active research sites sharing their innovative strategies for navigating this evolving landscape. While universal solutions are elusive, each site employs a unique blend of technology and human expertise to achieve its research objectives.
CEU: 1.00 ACRP
Speakers:
Meghan Degele, Sr. Director, Tempus AI
Tiffany Kirkpatrick, PharmD, ACRP-CP, Cancer Research Quality Program Manager and Research Pharmacist, Avera Cancer Institute
Ashley Servais, Director of Clinical Research, Nebraska Cancer Specialists
Alexis Wilson, Research Clinical Operations Coordinator, MemorialCare
The clinical research enterprise often attracts the kind of perfectionists who feel crushed when they make mistakes. They take failure personally, and, in an industry where every "i" and "t" are quality checked, their shortcomings are always noticed. But, what if we could build a clinical research team that promotes inclusion, learning, expression, and contribution--a team whose members no longer wake up in the night wondering if they forgot a signature during the monitoring visit? This session will promote the values of psychological safety in the workplace, and empower listeners to identify psychological safety principles and the impact on teams that lack them. Participants will be guided through real-life monitoring scenarios, learn what went right or wrong, and practice applying the four stages of psychological safety.
CEU: 1.00 ACRP
Speakers:
Amanda Egan, CCRP, Clinical Research Associate, Merck
Carli Lettrich, Senior Clinical Research Associate, Merck
Kyle Niquette, CCRA, Clinical Research Associate Manager, Merck
Watch a Sneak Peek into the Session Content:
Clinical research teams manage millions of data points and thousands of documents—yet many still rely on manual, time-consuming processes that slow progress and increase risk. The good news: There are accessible AI and automation tools within your office suite that can significantly streamline everyday tasks. Join experts in clinical research operations as they share practical use cases, share insights, and discuss how you can build confidence and expertise in this rapidly changing field. Specific topics include reducing the AI fear factor, building an AI-informed workforce, and tackling clinical research operations with AI.
CEU: 1.00 ACRP
Speakers:
Burak Aktan, Head of Business Operations, Clinical Sciences and Study Management, Merck
Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus
Andrew Gordesky, Regional Director, Clinical Quality Management Latin America, Merck
Sandra Koseoglu, Director/ Program Lead, Clinical Sciences and Study Management, Merck
Chelsea Osterman, MD, Executive Medical Director, Tempus AI
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck
Karen Strat, PhD, Clinical Scientist, Merck
Turnover among clinical research professionals increases trial costs, delays timelines, and compromises data quality. Across sponsors, contract research organizations, health systems, and academic sites, workforce instability puts studies—and outcomes—at risk. This session shares a case study from the healthcare sector, where investing in psychological safety through expert-led group coaching led to a 20-point drop in annual turnover and $32 million in annual savings—while improving team performance and engagement. Psychological safety—the belief that team members can speak up and take risks without fear—is a proven driver of retention, operational efficiency, and proactive problem-solving. Group coaching embeds this mindset into team culture, enabling trust, reducing errors, and supporting sustainable performance. Attendees will leave with practical strategies to apply this low-lift, high-impact approach to onboarding, leadership development, and daily operations.
CEU: 1.00 ACRP
Speakers:
Francie Jain, Founder & CEO, Terawatt, Inc.
Tommy Thomas, CEO, Opposite Strengths Licensing, LLC
Research teams are being asked to do more with less—especially when it comes to unfunded or underfunded studies. Whether it’s supporting investigator-initiated trials with no startup budget or absorbing hidden costs from sponsor studies, the financial strain is real. This session offers practical strategies for identifying and managing financial risk at the site level. We’ll walk through tools for feasibility screening, cost recovery, and portfolio-level decision-making. Attendees will leave with insights they can use to engage investigators and institutional leaders in honest conversations about what it really costs to “just get it done.”
CEU: 1.00 ACRP
Speaker:
Shannon Chism, Education & Research Consulting Sr. Director, Huron Consulting Group
Back by popular demand and reimagined for 2026, the ACRP Game Show returns with more energy, more surprises, and more chances to test your knowledge in this high-energy session. Teams of clinical research professionals will go head-to-head in a fast-paced trivia battle covering everything from ICH-GCP principles to eClinical technology, informed consent essentials, and more!
Audience members won’t just watch—they’ll play along, cheer on their peers, and maybe even walk away with bragging rights. Whether you're a seasoned expert or a curious newcomer, this session is your chance to learn, laugh, and celebrate the clinical research enterprise in a whole new way.
CEU: 1.00 ACRP
Speakers:
Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen
Lexi Herbert, Launch Manager, TrialScreen
Watch a Sneak Peek into the Session Content:
Technology rollouts in clinical research struggle when change isn’t managed effectively. This session explores how to lead successful transitions to site-based eClinical solutions like electronic investigator site files, electronic source, and participant engagement platforms. The session will highlight common pitfalls in site-level implementations and how to avoid them through proactive communication, pilot workflows, and leadership alignment. Designed for site leaders and operations professionals, the session focuses on practical, real-world strategies for overcoming resistance, fostering cross-functional buy-in, and building adoption plans that last beyond go-live. Attendees will walk away with a clear framework on how to engage stakeholders early, design training that sticks, and track meaningful adoption metrics.
CEU: 1.00 ACRP
Speaker:
Alicia Gearhart, Director of Professional Services, RealTime eClinical Solutions
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U.S. Food and Drug Administration (FDA) inspections can be high-stakes events for clinical research sites, especially within large site networks. Yet, many sites and quality assurance (QA) teams only engage reactively, leading to inconsistent readiness and potential regulatory exposure. This session presents a proactive, collaborative model for ongoing alignment between site operations and the network’s QA function. Through real-world examples and practical tools, we’ll demonstrate how early QA involvement, open communication, and joint preparation foster a culture of continuous inspection readiness. Attendees will leave equipped with actionable strategies for collaborative mock audits, risk-based Corrective and Preventive Action (CAPA) plan implementation, and quality-focused training that empowers staff and mitigates FDA risk.
CEU: 1.00 ACRP
Speakers:
Margaret (Meg) Rood, VP, Operational Excellence, IMA Clinical Research
Andreja Vlajankov-Salaj, Sr. Director, Quality Assurance, IMA Clinical Research
Step into the ACRP 2026 Video Kiosk and share your story! Celebrate a standout conference moment or reflect on how membership, certification, or the ACRP community has supported your growth as a clinical research professional. Your voice can inspire others—and it only takes a few minutes to record.
Research sites often juggle multiple sponsor-required technology systems across their studies. This patchwork of systems can lead to duplicative data entry, repeated training, and inefficient workflows that add significant administrative burden to already demanding workloads.
This session will introduce a new AI-powered ChatGPT-like experience for protocol and study document review, and how using site-preferred systems—including the electronic medical record (EMR) and clinical trial management system (CTMS)—can help researchers and coordinators work more efficiently in sponsor-led trials. We will discuss workflows that integrate with existing systems and explore how greater flexibility in technology choices can reduce duplicate work and streamline daily study tasks.
Attendees will gain a practical understanding of how Bring Your Own Technology BYOT approaches are evolving across the clinical research ecosystem and how leveraging familiar systems can simplify study operations.
This session does not provide ACRP Contact Hours.
Speaker:
Keith Wright, Sr. Director, Strategy, Advarra
Informed consent is a cornerstone of ethical research, but without accounting for health literacy, it often fails to ensure true participant understanding. This session will explore how research professionals can bridge the gap between regulatory compliance and meaningful comprehension, particularly in sensitive fields like reproductive health. Drawing from real-world experience in Phase III trials, biorepository studies, and community health research, I will share practical strategies for improving the consent process using plain language, teach-back methods, and visual aids. We’ll also examine relevant ICH-GCP guidelines, including the requirement that consent information be presented “in a language understandable to the subject,” and discuss how these principles apply in daily research practice. Attendees will leave with actionable tools to support participant-centered communication and to elevate the informed consent process beyond a signature to a personal, nuanced, and regulatory-compliant conversation that leaves patients feeling empowered in their decision.
CEU: 1.00 ACRP
Speaker:
Gianna Gemignani, BS, ACRP-CP, Clinical Research Project Coordinator, University of Wisconsin-Madison School of Medicine and Public Health (Department of OB/GYN)
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An exclusive, invitation-only event honoring the 2026 Class of Fellows and offering a special opportunity to connect with peers.
Enjoy your favorite specialty coffee and an extra afternoon boost in Booth #411.
Break for lunch and discuss what’s next—connect with your community, share your top takeaways with your peers, and discover solutions from 50+ trailblazing organizations throughout the Expo Hall.
Be sure to leave time to visit at least 10 exhibitor booths to collect stamps for your Go for Prizes card!
Have a complimentary headshot taken to build professional credibility and make a great impression.
Take time to learn about our poster presentations, ask questions, and engage directly with their work. Attendees can also vote for their top three poster presentations in two categories: student and non-student.
Winners will be announced Sunday at 5:30 PM at the Expo Hall Main Stage.
Sites are overwhelmed by the increasing number and complexity of technology solutions required to execute clinical trials. This is exacerbated by the increasing number of solution providers selected. Currently, research sites are typically required to use sponsor-provided technology systems. The Decentralized Trials and Research Alliance's (DTRA's) "Bring Your Own Technology" initiative aims to enable clinical research sites to use their own validated technology systems in industry-sponsored clinical trials while maintaining regulatory compliance and sponsor oversight. The objective is to reduce operational inefficiencies, improve data quality, and enhance site and patient experiences. This session will share the work done by DTRA to date to define a process to enable adoption of site-preferred technology in registrational trials. Using eConsent as a model, key considerations and impact assessments conducted to identify opportunities and challenges from a multi-stakeholder perspective will be shared. The work continues in 2025-26, focusing on site-preferred eSource adoption by sponsors.
CEU: 1.00 ACRP
Speakers:
Joe Dustin, Founder and Principal, Dauntless eClinical Strategies
Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions
Watch a Sneak Peek into the Session Content:
Training challenges persist throughout the clinical research enterprise. This session presents benchmark data and discusses practical solutions for partnerships between sponsors, contract research organizations, and sites to address site-based training shortcomings for the betterment of clinical trial conduct.
CEU: 1.00 ACRP
Speaker:
Jimmy Bechtel, Vice President, Site Engagement, SCRS
Study startup delays represent a critical barrier impairing efficiency in clinical research timelines and our ability to ultimately serve patients. Tackling each contributing factor in this issue should be an effort we all engage in. The Site-Sponsor Consortium—a unique collaboration of sponsors, contract research organizations, institutional sites, and commercial sites—will unveil its inaugural whitepaper, which details actionable strategies to simplify and harmonize Confidentiality Disclosure Agreement processes across the industry. Consortium members will discuss the operational and ethical imperatives for reform, the value of master and bilateral agreements, and the collaborative journey that led to consensus-driven solutions. Attendees will gain insight into the practical steps needed to reduce study startup timelines and foster a culture of shared responsibility, transparency, and innovation in clinical research.
CEU: 1.00 ACRP
Speakers:
Carlos Orantes, Chief Executive Officer, Alcanza Clinical Research
Michelle Rowe, RN, VP, Research, HCA Healthcare
Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Brandi Walker, Executive Vice President, Clinical Development Operations, Syneos Health
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Clinical research can be made more trustworthy and accessible by engaging communities through unconditional, literacy-driven outreach. This session shares a model for engaging people where they are, not as future participants or workforce members, but as community members deserving of clarity, inclusion, and respect. Presenters will share examples of how they deliver plain-language education about clinical research, facilitate conversations around research mistrust, and equip communities with the tools to navigate research information and options. These efforts aren’t tied to active studies or enrollment; rather, they’re grounded in the belief that long-term public trust is built through repeated, agenda-free education. Attendees will walk away with replicable strategies for building community-facing literacy initiatives centered on equity, transparency, and relationship-building.
CEU: 1.00 ACRP
Speakers:
Addison Gumbert, Clinical Research Marketing Strategist, Premier Clinical Marketing
Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
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Clinical trial recruitment often fails not because patients do not exist, but because they are never identified. Specialty private practices hold large, underutilized patient populations, yet recruitment strategies still rely on static feasibility surveys and manual chart review.
This session introduces a data-driven approach that begins with a retroactive audit of existing patient records to quantify true trial feasibility, followed by real-time identification of eligible patients directly within clinical workflows. By structuring both structured and unstructured EHR data, sites can surface eligible patients continuously without manual effort.
Using real-world deployments, we will show how this model replaces guesswork with measurable patient availability, reduces screening burden, and enables faster, more predictable enrollment. The result is a shift from reactive recruitment to a continuous system aligned with how care is actually delivered.
This session does not provide ACRP Contact Hours.
Speaker:
Ayush Jain, Co-Founder and CEO, Syntra
The relationship between clinical research coordinators and monitors is at the heart of every trial. Too often, it is defined by miscommunication, mistrust, and turf wars, but clinical trials move too quickly and are too important to allow these avoidable barriers to persist. This interactive session, led by monitors who were once coordinators, flips the script. With a unique dual perspective of site and sponsor, the speakers explore how empathy, communication, and perspective-taking can transform this critical relationship from adversarial to collaborative. Attendees will gain heightened self-awareness and actionable strategies for their unique situations. When coordinators and monitors work in sync, clinical trials run smoothly. Let's rethink the status quo and co-create a culture of mutual respect and shared goals--because better relationships mean better research.
CEU: 1.00 ACRP
Speakers:
Jodie Addington, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences
Kelly Chan, BS, CCRA, Manager, Clinical Research Monitoring, Edwards Lifesciences
Misty Daniel, CCRC, CCRA, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences
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Does working with your IRB feel like a roadblock? With the right strategies, you can develop a powerful partnership to ensure ethical, efficient, and compliant research.
In this session, participants will learn how to communicate with the IRB in ways that reduce delays, improve protocol clarity, and support ethical decision-making. Grounded in real-world IRB review practices, federal regulations (45 CFR 46), and institutional experience, we’ll explore what the IRB actually prioritizes in a protocol submission and how to deliver a clear and concise submission for review.
We’ll cover how to describe study activities in a way that aligns with regulatory criteria, write protocols with clarity around data handling, participant interactions, and multi-site coordination, and navigate pushback or differing IRB interpretations. Whether you’re managing a straightforward survey study or a complex, multi-site data integration project, this session will equip you with strategies to make your IRB submissions more efficient and effective.
CEU: 1.00 ACRP
Speakers:
Rachel Lally, MPH, CIP, Assistant Vice President for Research, Penn State University
Challace Pahlevan-Ibrekic, Director, Clinical Research, Northwell Health
The ACRP 2026 Conference Advisory Working Group (CAWG) works closely with ACRP staff to develop the program for the Annual Conference. Drawing on their diverse experience and real-world knowledge of the clinical research industry, CAWG members provide expert guidance on educational programming and offer detailed feedback as part of the submissions review process.
If you are interested in joining the CAWG, please complete this interest form. Several CAWG members will be at ACRP Booth #531 in the Expo Hall from 2:15 - 3:00 PM on Saturday and Sunday to share information about the Conference Advisory Working Group for ACRP 2027.
Take a breather and make meaningful connections—mingle with exhibitors and colleagues in the Expo Hall during this afternoon networking break.
What if the real obstacle to better recruitment isn’t your budget or your systems... but how you communicate? Too often, clinical teams overlook the role personality plays in how messages are delivered, received, and acted on in both internal departments and patient communications. And believe or not, they coorelate more than you think.
This session explores how internal misalignment in communication can spill over into patient-facing interactions, impacting trust and clarity (and ultimately recruitment & retention). Using personality test frameworks like DISC, MBTI, and others, we’ll explore our own communication preferences, categorize communication styles of others, and how to adjust your approach to build stronger connections. When applied to patient recruitment, strong communication builds greater trust with patients by showing an understanding of who they are, their priorities, and how they communicate. When patients feel understood, you earn their trust.
When communication flows, recruitment follows.
CEU: 1.00 ACRP
Speaker:
Addison Gumbert, Clinical Research Marketing Strategist, Premier Clinical Marketing
This session will discuss the implementation a novel tool for Identifying IRB Review Level for Studies involving Secondary Use of Data/Specimens.
CEU: 1.00 ACRP
Speaker:
Leslie Bell, Regulatory Specialist, Medical University of South Carolina-South Carolina Clinical and Translational Research Institute (SCTR)
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Discover how prioritizing soft or aligned skills in hiring and training entry-level clinical research professionals can open sustainable pathways to success—and learn how to put skills-based hiring into action at your institution. We’ll briefly examine industry trends and the importance of a sustainable talent pipeline with the right skills. We will share our real-life experiences building a workforce development program, and provide tools for screening, hiring, and developing the desired soft skills. Participants will reflect on their own institutional needs and practices, and come away with actionable strategies to create inclusive, skills-based paths into the profession. By revisiting the Joint Task Force for Clinical Trial Competency model through the lens of your institution’s prioritized soft skills, you’ll assess alignment, identify gaps, and explore ways to refine expectations—ensuring your training goals and performance benchmarks are appropriate and personalized.
CEU: 1.00 ACRP
Speaker:
Kathleen OMalley, BSN, CCRP, Director of Education and Training, Jefferson Clinical Research Institute, Jefferson
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Clinical trial recruitment faces persistent challenges, including prolonged enrollment periods, high screen failure rates, and inconsistent data quality. This session introduces the innovative block enrollment strategy, which accelerates trial recruitment by concentrating all site resources on a single protocol during a focused enrollment period. By aligning the entire research team and optimizing patient engagement, the block enrollment approach improves enrollment efficiency, reduces screen failures, and enhances participant retention. Drawing on real-world data from ophthalmic trials, attendees will explore how this model streamlines workflows while maintaining rigorous quality standards. The session will engage participants in discussing scalability and adaptation of block enrollment across various therapeutic areas. Key roles of principal investigators, study coordinators, and support staff in this focused recruitment method will be highlighted. Attendees will have the opportunity to learn about a transformative, practical approach that reshapes clinical trial enrollment and optimizes site performance.
CEU: 1.00 ACRP
Speaker:
David Almeida, MD, MBA, PhD, President and CEO, Centers for Advanced Surgical Exploration (CASEx) and Erie Retina Research
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Decentralized clinical trials are reshaping how research is conducted, offering new opportunities to expand access, improve participant accrual, and reduce the burden on limited organizational resources. This session will explore transformative approaches institutions can take to implement and manage decentralized trials effectively. Attendees will learn how to adopt flexible models that support research growth without requiring extensive staffing or infrastructure. The session will highlight practical strategies for integrating decentralized elements into existing workflows, including virtual visits, digital tools, and participant-centered processes. Real-world examples will show how organizations have successfully used decentralized models to reach underserved populations and streamline operations. Whether the organization is beginning to explore decentralized research or looking to scale existing efforts, this session will provide actionable insights to help align trial design with institutional goals. Attendees will discover how decentralized research can be a powerful tool for increasing efficiency, expanding reach, and supporting sustainable research operations.
CEU: 1.00 ACRP
Speaker:
Shreya Singh, Consulting Sr. Associate, Huron Consulting Group
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This session proposes a new operational paradigm focused on redesigning the internal structure of clinical trial sites through the incorporation of specialized roles--with active support from the industry--to ensure quality, efficiency, and long-term sustainability. The presenter will analyze the structural limitations of the traditional site model and their implications for quality, compliance, and efficiency; demonstrate the strategic value of new key roles such as clinical trial managers, quality control specialists, quality assurance specialists, clinical trial educators, and clinical research coordinator assistants; present a scalable framework based on quality management systems (QMS) that integrates these roles; and offer an action plan to transform site structures and strengthen the workforce.
CEU: 1.00 ACRP
Speaker:
Carlos Pinoargote, Chief Operating Officer, BRCR Global
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Learn a values-based framework to standardize budgets while honoring site needs, empowering advocacy, equity, and site sustainability.
CEU: 1.00 ACRP
Speaker:
LaTisha Weaver, Consultant - CEO, LDM Clinical Research Source
This session is designed for new project managers and those aspiring to move into a project management role. The focus is on the project manager’s role in feasibility planning, recruitment execution, and effective communication. While job titles and responsibilities may vary across sponsors and contract research organizations, this session underscores the core project management practices that support the primary goal of delivering clean, reliable data and protecting study participants—all while keeping the study’s timeline on track.
CEU: 1.00 ACRP
Speakers:
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
Mary Lord, RN, MS, CCRA, CRA Manager, Site Management and Monitoring, Merck
This session explores how to celebrate Gen Z colleagues, collaborate effectively with Millennial bosses, and embrace the strengths of a multigenerational workforce. Today’s organizations face new challenges as employees bring diverse values, attitudes, and expectations. Baby Boomers represent 15% of the workforce, Gen X 31%, Millennials 36%, and Gen Z 18%.
Participants will learn to identify and compare generational core values and cultural influences to enhance communication and build high-performing, inclusive teams. The session highlights recognizing personal biases and avoiding snap judgments about other generations.
A key focus is the paradigm shift from a traditional “boss” mentality to a “coach” approach, fostering trust and engagement across age groups.
In the clinical research community, where collaboration is critical, each generation contributes unique strengths and perspectives. This session equips attendees to support intentional cross-generational communication, encourage mutual understanding, and leverage diversity to strengthen teamwork and improve outcomes in this dynamic environment.
CEU: 1.00 ACRP
Speakers:
Yekatrina Tsabur, Organizational Consultant, Sophos
Yelena Tsabur, Organizational Consultant, Sophos
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This session will highlight the transformation of protocol activation and lifecycle management that results in improved research billing compliance, streamlined workflows, aligned financial policies, and enhanced training curriculum. Despite the complexity of study activation, we found that mastering the basics—clear policies and procedures along with practical tools—was key to success. Attendees will leave with strategies and tools to confidently support clinical trial workflow transformation projects.
CEU: 1.00 ACRP
Speakers:
Chad Eriksen, MS, CCRC, FACRP, President, Strategic Advisor / Sr. Project Manager – Yale Center for Clinical Investigation (YCCI) Iron Horse Research
Kayleen Joyce, MS, CCRC, ACRP-PM, Consulting Manager, Huron Consulting Group
This session will delve into the critical role of academic medicine in clinical research, exploring why it is considered the pinnacle of clinical trials. We will discuss the historical and current challenges faced by academic researchers and how they are navigating the modern clinical trials environment. The session will review the impact of startups, technology, data, patient engagement, and newer political challenges on medical research. We will also identify solutions for current bottlenecks in academic research and propose strategies for moving forward and thriving in the current environment. Attendees will gain valuable insights into the evolving landscape of clinical research and the innovative approaches being employed to overcome obstacles. The session will conclude with a Q&A segment, allowing for an interactive discussion with the audience.
CEU: 1.00 ACRP
Speaker:
Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center
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The question of how—and how much—to compensate research participants is far from settled. While undue influence remains a central concern, too little compensation can be equally problematic—failing to respect participants’ time, reinforcing inequities, and limiting recruitment from underrepresented groups. What truly constitutes "undue influence"? Should compensation only reflect time and inconvenience, or also acknowledge risk? Do higher payments undermine voluntariness, or do they simply acknowledge the realities of participation? This session will examine current debates alongside emerging trends, including reimbursement versus compensation, digital wallet payments, gamification, and punitive terms of payment. Drawing on ethical frameworks, regulatory guidance, and real-world case examples, we will provide attendees with practical tools to evaluate and justify compensation strategies that withstand scrutiny while supporting participant trust and engagement.
CEU: 1.00 ACRP
Speaker:
Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB
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Have a complimentary headshot taken to build professional credibility and make a great impression.
Connect with your colleagues and 50+ leading-edge organizations and suppliers helping you get better results in clinical research.
Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.
If you’ve collected stamps from 10 booths, drop off your prize card at the ACRP booth #531 and be there at 5:00 and 5:15 for your chance to win one of our high-value giveaways, including an iPad, a Breville Espresso Machine, a YETI Soft Cooler, gift cards, and more—must be present to win!
When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.
Find your calm in the Zen Den—a quiet retreat where you can unwind, reset, and take a breather from the hustle of the conference. Color your sketchbot, relax with mindful activities, or simply enjoy a peaceful moment to yourself.
Step into Connection Cove—a relaxed space designed for casual chats and low-pressure networking. Come as you are; we’ve got conversation starters and ideas to make meeting others feel natural.
Join us for a closing-day mindfulness session designed for clinical research professionals to reflect, integrate, and leave with clear next steps. Led by Cem Murdun, President of the ACRP Suncoast Chapter, this 30-minute practice blends focused attention and brief embodied reflection to help you consolidate key learnings and return to work with greater clarity and intention.
Let us know if you plan on attending this meditation session by filling out this form. Space is limited to 25 attendees.
Step into the ACRP 2026 Video Kiosk and share your story! Celebrate a standout conference moment or reflect on how membership, certification, or the ACRP community has supported your growth as a clinical research professional. Your voice can inspire others—and it only takes a few minutes to record.
Start your day with a delicious breakfast and engaging conversations in the Plaza/Regency Foyer on the final day of ACRP 2026.
Minoritized populations have historically been underrepresented in clinical trials. Speakers for this panel from a research center located in an underserved California community that is 80% Latino have found that observational trials—when strategically implemented—can build trust and engagement. Panelists will share their experiences with an Alzheimer’s disease observational study that became a catalyst for broader community involvement. The site achieved top-three national enrollment, increased Latino participation, and fostered partnerships with local community centers and adult day programs. The effort significantly improved health literacy and facilitated acceptance of interventional Alzheimer’s trials. The center's site director, manager, study coordinator, pre-screener/recruiter, and community engagement representatives will highlight key strategies across all stages of the trial, demonstrating how observational studies can enhance community engagement, reduce stigmas related to trial participation, and lay the foundation for future research.
CEU: 1.00 ACRP
Speakers:
Emilia Alcala, Clinical Research Coordinator, Sun Valley Research Center
Leslie Michelle Dowling, Site Manager, Sun Valley Research Center
Judy Galindo, CCRC, Executive Director & Site Co-Owner, Sun Valley Research Center
Vanessa Nuño, Community Engagement Representative, Sun Valley Research Center
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This session will provide key topics in keeping up with new monitoring techniques in the dynamic atmosphere of decentralized clinical trials. We will explore how to use modern systems and technology to aid in efficiency in monitoring both virtual decentralized clinical trial sites and brick and mortar sites participating in decentralized clinical trials.
Topics examined will include a discussion of systems used in decentralized sites and decentralized trials, navigating these systems, and creating bespoke methods of monitoring to respond to novel models of clinical trials.
CEU: 1.00 ACRP
Speaker:
Jessica Carlson, BA, CCRA, Sr Clinical Research Associate, Apogee Therapeutics
In the clinical research industry, the importance of cultivating strong, trusted relationships between sponsors, sites, and patients is widely acknowledged as a key factor for clinical trial success. However, building and nurturing these relationships can be more challenging than it may appear. Upon closer examination of the underlying issues reveals that communication barriers and a lack of mutual understanding between stakeholders often hinder trial efficiency. This session will explore how professionals with experience on both the site and sponsor side of clinical research are uniquely positioned to bridge the gap. By providing sponsors with valuable insights into site challenges and patient needs while simultaneously empowering sites to better understand the sponsor’s objectives, we aim to foster the right relationships necessary for effective collaboration. When executed correctly, this approach can improve recruitment and retention, ensure higher data quality, and ultimately lead to more successful trials.
CEU: 1.00 ACRP
Speakers:
Summer Borsack, Associate Clinical Research Associate, Merck
Doris Chang, Associate Clinical Research Associate, Merck
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Protocol deviations, if not properly identified and addressed, can jeopardize participant safety, data integrity, and trial credibility. The FDA’s December 2024 draft guidance on "Protocol Deviations for Clinical Investigations" introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those deemed “important.” This session will provide attendees with a practical framework to align their practices with the evolving regulatory landscape. Through real-world case scenarios and an interactive exercise, participants will learn how to evaluate deviations using a risk-based approach and strengthen communication with institutional review boards and sponsors. We will also analyze emerging tools, including automation and artificial intelligence, that support proactive deviation detection and inspection readiness. Designed for clinical operations teams, site staff, and quality assurance professionals, this session combines compliance essentials with forward-looking strategies.
CEU: 1.00 ACRP
Speakers:
Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training
Meghana Rao, Sr. Manager, Clinical Trial Lead, Olema Oncology
Kaushal Shah, PhD, Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs, Arizona State University
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As the ICH E6(R3) guideline reshapes expectations for Good Clinical Practice, organizations must go beyond compliance to embed risk-based thinking and critical-to-quality practices across functions. This panel brings together senior leaders to share firsthand experiences of putting the new guideline into practice—from big-picture strategy to everyday decision-making. Panelists will discuss how critical thinking supports better choices, where risk-based approaches add the most value, and lessons learned in leading the cultural mindset shift needed for sustainable quality practices. Attendees will walk away with practical strategies to lead change, collaborate across functions, and build systems that last.
CEU: 1.00 ACRP
Speakers:
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy
Emma Pinto, BA, MBA, Manager, Clinical Trial Education & Communications, Kaiser Permanente Northern California Clinical Trials Program
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Jennifer Tugwell, MSN, RN, ACRP-CP, Sr. Manager Clinical Trials Education, Training & Policies, City of Hope
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Join us for an inside look at how the Center for Clinical Research Management (CCRM) transformed its onboarding approach to meet the evolving needs of today’s clinical research environment. This session explores the creation of a scalable, flexible, and role-specific training program that balances standardization with individualization. Discover how platforms like Microsoft Teams, REDCap, and OnCore CTMS were integrated to enhance training, compliance, and collaboration. We’ll share key lessons, data insights, and practical tips to help you build or refine your own onboarding systems.
CEU: 1.00 ACRP
Speakers:
Amber Anaya, MS, CCRP, Clinical Research Manager, The Ohio State University
Kelly Dunsky, MS, CCRC, Associate Director of Clinical Research Operations, The Ohio State University
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Grab a quick pick-me-up in the Plaza Foyer—caffeine and conversation await to keep your final day at ACRP 2026 buzzing.
This fast-paced, highly interactive lecture helps clinical research and quality professionals move beyond terminology and into real-life application. Participants will examine practical strategies and thinking to implement oversight, Quality by Design (QbD), and risk-based thinking in day-to-day trial decisions. Drawing on ICH E6(R3) expectations and real-world examples from both site and sponsor perspectives, the session includes guided activities and tools that help translate regulatory concepts into operational action. Attendees will also gain practical insight into two additional ICH E6(R3) expectations—data governance and fit-for-purpose thinking—showing how these concepts apply to system design, oversight, and proportional quality approaches. Interactive elements such as Buzzword Bingo, live polling, and decision-based scenarios reinforce key concepts and encourage critical thinking. This session is ideal for site and sponsor professionals seeking clarity, confidence, and practical insight into applying ICH E6(R3) in the real world.
CEU: 1.00 ACRP
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Clinical research coordinators (CRCs) are the backbone of trial execution, yet many sites lack a structured, competency-based approach to support their development beyond onboarding. This session introduces a tiered CRC Competency Checklist designed to guide coordinators from beginner through advanced levels of practice. Originally developed for an independent research site, the checklist integrates the Joint Task Force Core Competency Framework and ACRP’s CRC Competency Development and Assessment Roadmap with practical, observable skill demonstrations—promoting role clarity, professional growth, and high-quality performance. Attendees will explore how this adaptable tool fosters ongoing workforce training, simplifies evaluations, and builds a culture of excellence. This session is designed for mid-level professionals seeking to improve training programs and enhance team performance. This session aligns with ACRP’s Workforce Development and Training focus by offering a sustainable method to invest in the growth and retention of CRCs across the industry.
CEU: 1.00 ACRP
Speakers:
Jesse Fuhriman, Clinical Research Coordinator, Rocky Mountain Clinical Research
Brittani Holden, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research
Kelsie Wetzel, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research
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This session will explore the goals of, and lessons learned from, migrating clinical trial data between two different electronic data capture (EDC) systems. Attendees will gain insight into preparing for and executing data migration, including data mapping and validation strategies. We will highlight challenges such as mapping issues, EDC differences, data integrity, and disruptions to study sites. We will discuss investigator site support, new tool training, and data collection during EDC downtime. Real study examples will highlight planned processes versus actual tasks completed. This session will outline best practices for enhancing study-team communication, managing timelines, and maintaining data quality. By the end of this session, attendees will understand the steps needed for planning a data migration, supporting sites during the migration, and applying lessons learned to maintain data integrity and prepare for future EDC transitions. This session is ideal for data managers, clinical operation staff, site staff, and investigative teams.
CEU: 1.00 ACRP
Speaker:
Abby Loden, MPH, Lead Data Manager, TRiNDS LLC.
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Utilization of Decentralized Clinical Trial (DCT) elements expanded rapidly during the COVID‑19 pandemic, when traditional research pathways were disrupted and remote participation became essential. After the pandemic, Sanford built on the operational and regulatory momentum gained to broaden both the scope and reach of its DCT program. This work continues through strong collaboration with key internal partners and external stakeholders, ensuring the program evolves to meet patient needs, regulatory expectations, and community priorities.
CEU: 1.00 ACRP
Speaker:
Lora Black, RN, MPH, OCN, ACRP-CP, Vice President of Clinical Research, Sanford Health
Clinical studies rely on seamless collaboration between sponsors, contract research organizations (CROs), and site teams. However, misalignment, communication breakdowns, and unclear expectations can slow progress and lead to frustration across all teams. This session will explore how to strengthen these essential relationships to accelerate study timelines, improve data quality, and reduce burnout. Drawing on real-world case studies and audience input, we’ll examine the most common pitfalls in sponsor-CRO-site dynamics and offer practical strategies to drive collaboration and trust.
CEU: 1.00 ACRP
Speakers:
Anna Rillo, BSN, RN, Associate Study Director, Bright Research
Claire Swan, Clinical Research Associate, Bright Research
Related Blog Content
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Manual data entry drains site resources and delays trial timelines, especially as studies grow in complexity, volume, and number of sources. However automated electronic health record-to-electronic data capture (EHR-to-EDC) integration can dramatically reduce site burden when it’s designed with usability in mind. This session explores what it really takes to make eSource and EHR-to-EDC work for sites: no new systems, no additional logins, no information technology support—just streamlined, intuitive workflows that fit naturally into how research coordinators already work, drawing on experiences from dozens of oncology trials across academic and commercial research settings. Attendees will gain actionable insights on how EHR-connected workflows can save time, reduce errors, and improve monitoring through traceable data capture, plus practical best practices for improving execution, supporting smarter source data verification, and scaling eSource without added complexity.
CEU: 1.00 ACRP
Speakers:
Samir Jain, VP, Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata, Dassault Systemes
Milijana Ugrenovic-Petrovic, Senior Director, Clinical Trials Office, Moffitt Cancer Center
Related Blog Content:
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Participant payments, reimbursements, and compensation policies vary widely across sponsors, sites, and geographies—leading to confusion, inequity, and potential barriers to enrollment. This session will explore the current landscape of participant benefits in clinical trials and propose a framework for standardization that balances ethical, operational, and regulatory considerations. Drawing on real-world case studies, stakeholder feedback, and emerging policy trends, we will present actionable strategies to modernize and harmonize how we support trial participants—especially those from underrepresented communities.
CEU: 1.00 ACRP
Speaker:
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
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Clean data don't just fall from the sky. They are the result of smart systems, agile teamwork, and strong protocol design. We’ll walk through real-world cases involving National Institutes of Health-funded clinical trials launched during the pandemic and adapted for decentralized and hybrid delivery models. Attendees will learn how to navigate complex databases even when study teams lack experience with Good Clinical Practice, design usable workflows from complicated protocols, and handle unexpected data management hurdles. We’ll share wins, near-misses, and lessons learned from integrating mobile apps, multiple electronic data capture platforms, Veterans Affairs systems, and real-time secure file transfer protocols. We’ll tie it all together using coordination science principles to show how better communication, shared understanding, and team alignment can lead to cleaner data and fewer deviations. Come for the strategy, stay for the stories, and leave with tools to clean up your own data chaos.
CEU: 1.00 ACRP
Speakers:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Jamie Dwyer, MD, Assistant Vice President for Clinical Research, University of Utah
John VanBuren, PhD, Senior Faculty Biostatistician, University of Utah
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Sponsors are revolutionizing the site experience by leveraging artificial intelligence (AI) to develop a survey automation tool, significantly simplifying the site feasibility survey process. This tool aims to reduce administrative burdens, enhance data accuracy, and provide real-time support, making it easier for sites to participate in clinical trials. Beyond current metrics, AI is also employed to identify the best-fit sites by creating an optimal potential site list based on extensive priorities. This includes tiering sites according to past performance, quality, and proximity to diverse catchment areas. By integrating these advanced AI-driven techniques, sponsors ensure that the site selection process is efficient, inclusive, and of the highest quality. These efforts not only streamline operations but also foster stronger collaborations with sites, ultimately advancing clinical research and improving patient outcomes.
CEU: 1.00 ACRP
Speaker:
Bonnie Lam, Feasibility, Strategy and Analytics Lead, Pfizer Inc.
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Patient recruitment and retention can be enhanced by understanding patients, building strong relationships, and fostering a connected, engaged community. This session explores the paradigm shift from enrolling participants on a trial-by-trial basis to encouraging lifelong recruitment. Patients who feel part of a community and have strong relationships with sites are more likely to stay in studies and participate in future trials. The presenter will share strategies and tactics for turning the non-qualified leads--the hidden treasure for recruitment--into members of the patient community. Recruiting from this community is both efficient and cost effective. Through interactive polling and real-world case scenarios, this session demonstrates how a retention-first approach improves outcomes, reduces recruitment burden, and lowers costs. Attendees will leave with practical tools that they can apply immediately at their sites.
CEU: 1.00 ACRP
Speaker:
Anuj Bhargava, MD, MBA, CDCES, FACP, FACE, Founder, CEO & Medical Director, Iowa Diabetes
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A site’s greatest asset isn’t its technology—it’s its people. As clinical trials grow in complexity, building confident, capable teams is essential for quality execution and staff retention. This session introduces a practical, mentorship-based approach to empower site staff at all levels, drawn from real-world experience leading clinical teams through change and growth. Attendees will learn how structured onboarding, peer mentorship, and ongoing development improve protocol compliance, morale, and team stability. Whether you're training new coordinators, addressing burnout, or fostering internal leadership, this session offers actionable tools to strengthen site performance by investing in your people.
CEU: 1.00 ACRP
Speaker:
Dean Jang, Site Director, IMA Clinical Research
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To engage the future clinical research workforce earlier, our team created a collaborative summer camp for high school students. This session explores the facilitators and barriers to designing and implementing a curriculum across multiple academic institutions. Attendees will learn strategies to address challenges such as inter-institutional coordination, resource allocation, and maintaining consistent quality and engagement. We will share insights on effectively reaching high school students and fostering their interest in clinical research. Key findings include identifying success factors and obstacles in multi-institutional collaboration, applying a team science framework, and integrating Bandura’s Four Elements of Social Learning Theory into lesson planning. We will also present our evaluation methods, including pre- and post-tests, self-efficacy measures, and participant feedback. Finally, we will introduce a comprehensive toolkit for replicating the camp model, featuring lesson plans, evaluation tools, and best practices.
CEU: 1.00 ACRP
Speaker:
Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor & Director, Master of Clinical Research and Certificate Programs, The Ohio State University
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Fuel up with a tasty lunch and make the most of your final day at ACRP 2026—connect with colleagues, reflect on insights, and keep the momentum going.
This presentation explores how engaging communities at every stage of clinical research builds trust, promotes informed participation, and enhances recruitment efforts. The presentation will discuss various strategies for involving communities during the design, implementation, and dissemination of research findings, highlighting their benefits and challenges related to cost, feasibility, and timing; as well as sharing examples of successful community engagement initiatives. Attendees will learn how to identify the most effective engagement approaches for their studies and the importance of early community involvement in ensuring ethical and impactful research.
CEU: 1.00 ACRP
Speaker:
Bashar Shihabuddin, MD, MS, Assistant Professor, Nationwide Children’s Hospital
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As clinical research evolves, sites are challenged to streamline workflows while upholding rigorous regulatory standards. This presentation outlines an evidence-informed approach to modernizing research conduct through informatics and digital tools. The session will deliver actionable strategies for integrating computerized systems into clinical research infrastructure—including electronic source documentation, e-regulatory platforms, and billing compliance automation. The session will explore key performance indicators to assess site health, lessons learned from multisite consultations, and practical guidance for regulatory alignment across varied geographic regions. Emphasis will be placed on optimizing research operations in academic settings, promoting digital transformation, and fostering global collaboration. Attendees will gain tools to assess and enhance site-level research operations; implement informatics systems that support regulatory integrity; and align compliance strategies with evolving state and federal guidelines. This session is ideal for clinical research professionals, site directors, and compliance specialists seeking to advance digital integration and sustain high-functioning research programs.
CEU: 1.00 ACRP
Speaker:
Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences
As clinical research embraces digital transformation, traditional roles in data management and adjacent functions are rapidly evolving. The integration of artificial intelligence, automation, and advanced analytics is reshaping how we collect, clean, and interpret data, impacting not only data managers but also medical monitors, safety reviewers, and clinical monitors. This session will explore practical strategies for upskilling and reskilling existing talent to meet the demands of tomorrow's trials. Attendees will gain insights into identifying skill gaps, fostering a learning culture, and aligning workforce development with emerging technologies. We'll also discuss cross-functional implications and opportunities for collaboration as clinical operations and data oversight become increasingly interconnected. Whether you're leading teams or navigating change yourself, this session will provide a roadmap for talent transformation that keeps people at the center of innovation.
CEU: 1.00 ACRP
Speaker:
Tracy Parker, VP, Managing Director, IQVIA
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It is often straightforward to recognize FDA regulatory oversight when working on industry-sponsored studies conducted under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. However, clinical research professionals frequently encounter uncertainty when determining whether FDA oversight applies in less obvious scenarios, including investigator-initiated, multisite, or early-phase studies. This session will present a practical framework to help participants identify and flag FDA regulatory oversight by walking through key indicators of IND/IDE applicability, common misconceptions, and critical decision points that influence regulatory classification and IRB review. The session will also explore emerging regulatory considerations related to artificial intelligence and machine learning–based products, companion diagnostics, radiation-emitting devices, and digital health technologies. Participants will leave with practical decision tools, case-based examples, and communication strategies to support confident, compliant conduct of FDA-regulated research.
CEU: 1.00 ACRP
Speaker:
Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University
The advancement and rapid utilization of artificial intelligence (AI) scribes and other AI assistant tools in the clinical space raise new questions about what constitutes "source" for data in healthcare settings. During this discussion, we will look at AI scribe programs that are currently being used at major hospitals and clinics across the U.S. in order to identify concerns, discuss mitigations, and better understand what should be considered when conducting site qualification visits from a quality management perspective. For example, what is the source when the original records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artificially created notes and care plans? Does the institution have plans in place to ensure data integrity in the age of AI-generated notes?
CEU: 1.00 ACRP
Speaker:
Michele La Badie, ACRP-CP, ACRP-MDP, ACRP-PM, Clinical Trial Manager, Shoulder Innovations
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Training is an integral piece of the onboarding process for new staff in clinical research, but is often not approached systematically with evidence-based methodology. This session offers a framework for building efficacious and engaging orientation and training programs that emphasize problem-solving and critical thinking. Attendees will gain skills in identifying common areas of improvement in their own institution's programs and learn how to apply teaching theories and skills to improve their curriculum and align with Joint Task Force competencies. The presentation will culminate in reviewing methods of data collection to assess the impact of changes made to a training program.
CEU: 1.00 ACRP
Speaker:
Aja Macias, Clinical Research Educator, Stanford Cancer Institute
Signature Series Session
Clinical research is undergoing a dynamic transformation—propelled by breakthrough developments, evolving regulations, and fresh approaches to collaboration. In this fast-moving landscape, adaptability and strategic foresight are no longer optional—they’re essential for navigating what’s next.
David Burrow will offer strategic insights on elevating trial quality and minimizing regulatory uncertainty—sharing forward-thinking approaches and practical tools designed to help research professionals thrive in today’s complex and rapidly shifting environment.
Key topics:
Emerging trends shaping the future of clinical research
Foundational principles of Quality by Design
Leveraging the FDA’s CDER Center for Clinical Trial Innovation (C3TI)
The growing impact of artificial intelligence on trial design and execution
Actionable strategies for navigating periods of rapid change
Whether you're rethinking trial design, exploring new technologies, or seeking clarity in a changing regulatory landscape, you’ll leave this session equipped to lead with purpose and drive meaningful progress in a field that’s redefining what’s possible.
At the end of this session, attendees will be able to:
Explain how emerging trends shape the future of clinical research
Leverage Quality by Design (QbD) to mitigate regulatory uncertainty
Understand the FDA’s update on the CDER Center for Clinical Trial Innovation (C3TI)
Identify actionable strategies for clinical research professionals navigating periods of rapid change
Explain the impact of artificial intelligence on FDA inspections (so far)
CEU: 1.00 ACRP
Speaker:
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, U.S. Food and Drug Administration
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Using lessons learned from the implementation of the National Institutes of Health single institutional review board (IRB) mandate in 2018 and the Common Rule cooperative research provisions enacted in 2020, participants will explore how changes in the U.S. Food and Drug Administration (FDA) regulations requiring single IRB review, as proposed in 2022, would impact how clinical researchers get IRB approval for their studies. Building on the processes already in place nationally to have IRB review conducted by a single IRB, this session will discuss how the narrower scope of the FDA’s proposed single IRB requirements will necessitate that clinical research teams work more closely with their local IRBs and possibly the FDA prior to proposal submission. Participants will also learn more about the specific decision points required when considering whether the proposed FDA single IRB requirement applies to proposals.
CEU: 1.00 ACRP
Speaker:
Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
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