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Digitally Driven Compliance: Transforming Clinical Research Operations Through Informatics Integration

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

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