Signature Series Sessions
The ‘Signature Series’ sessions at ACRP 2025 will inspire, motivate, and prepare you for the future of clinical research. This year’s lineup includes thought leaders, regulatory officials, and industry experts driving innovation and change.
Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice
ICH E6 changes are upon us. Are you ready to implement the new GCP standards and a more flexible trial design framework? Join us for a panel discussion covering key updates from ICH E6(R3), the shift from ICH E6(R2), GCP implications, and practical tips for implementation.
Friday, April 25, 9:00 — 10:00 AM
Kassa Ayalew, MD, MPH, Director, Division of Clinical Compliance Evaluation, Office of Scientific Investigation, CDER, U.S. FDA
Katherine Mary Marangio, Learning Program Consultant, Parexel
Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University; President, ACRP Ohio Chapter
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Allison Massari, Interdisciplinary Artist, Executive Coach, Entrepreneur
Compassionate Care – You are the Medicine
Allison Massari, a burn survivor and resilience expert, knows first-hand the healing power of compassion. In this inspiring session, hear how you can be the remedy with simple acts of kindness that take seconds. Leave with actionable insights and ways to incorporate compassionate care into your clinical research practice.
Friday, April 25, 2:00 — 3:00 PM
FEAR: Face Everything and Rise (in Clinical Research)
Join Dr. David Burrow from FDA's Center for Drug Evaluation and Research as he discusses strategies for implementing Quality by Design and Risk-Based Quality Management Systems in trial design. Building on themes from his 2024 Signature Series, Dr. Burrow will offer practical approaches to overcoming obstacles and advancing clinical research innovation.
Saturday, April 26, 9:00 — 10:00 AM
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, CDER, U.S. FDA
Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc
Paul Ivsin, Executive Vice President, Trial Engagement Service, Continuum Clinical
Pamela Tenaerts, MD, Chief Scientific Officer, Medable
Actionable Insights for Transforming the Clinical Research Enterprise
Change in clinical research comes from all levels, but the voices of seasoned professionals have often been overlooked. This session will reveal input from 735 clinical research professionals who participated in ACRP's Transformation of the Clinical Research Enterprise Survey in early 2025. Hear actionable findings on how to improve clinical trials from those who implement and manage them, with insights into data quality, recruitment, hiring, and retention, technology, staff experience, regulations, and more.
Saturday, April 26, 2:00 — 3:00 PM
AI in Clinical Research
Artificial Intelligence (AI) is emerging, but don’t panic—join us for a panel discussion exploring its impact. We'll start with an introduction to AI basics and its implementation in clinical research. Our panelists will guide us through key points on responsible AI use and how we can collectively embrace its applications in clinical research.
Sunday, April 27, 8:00 — 9:00 AM
Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus
Pamela Tenaerts, MD, Chief Scientific Officer, Medable
Lisa Moneymaker, Head of Strategic Customer Engagement, Medidata Solutions
David Vulcano, LCSW, MBA, CIP, RAC, VP Clinical Research Compliance & Integrity, HCA Healthcare