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

This session is sponsored by

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

This session is sponsored by

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

• With the Right Approach, Vulnerable Populations Can and Should be Engaged in Research

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.

Sponsored by

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:

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: