ACRO's Good Clinical Podcast

What does the future of early-stage clinical research look like?In this episode, experts from clinical operations, IRB/regulatory oversight, and technology/policy — Amy Roach (Parexel), Bert Wilkins (WCG), and Jackie Ward (Veeva) — explore the evolving landscape of early-stage clinical trials in the U.S. From regulatory modernization and global competitiveness to interoperability, participant access, and increasingly complex trial designs, the discussion centers on how the U.S. can improve speed, efficiency, and predictability while preserving safety, rigor, and quality.

AI is transforming trial monitoring from a reactive process into a proactive, risk-driven discipline. In this episode, ACRO RBQM Working Group members Cris McDavid (Parexel), Shailesh Madel (ICON), and Linda Phillips (IQVIA), come together to examine how artificial intelligence and machine learning can help identify risks and signals faster while humans maintain accountability and oversight.From accelerating the identification of Critical-to-Quality (CtQ) factors and enhancing centralized monitoring to addressing concerns around pushing humans out of the loop, the discussion highlights both the challenges and opportunities ahead. With insights on how AI is already being leveraged to increase operational efficiencies while balancing patient safety and data integrity, this episode offers a glimpse into the future of centralized monitoring.

In this episode of ACRO's GCP, Tinaya Gray (Executive Director, Site Engagement & PACE at ICON plc), Jan Hewett (SVP, FDA Regulatory Advisor at Advarra), and Jackie Kent (Independent Advisor) unpack the work of ACRO's dive team on representative, generalizable clinical trial data at the 2025 Innovation Network Gathering. Together, they explore why clinical trial populations still fail to reflect real-world patients, and what's been holding the industry back from meaningful progress.The conversation goes beyond identifying the problem. The group shares how a diverse set of stakeholders were able to align around practical, implementable solutions. They also discuss how industry can pilot new approaches, engage broader stakeholders, and turn promising ideas into standard practice. This episode offers a candid and solutions-oriented look at how to generate clinical data that truly supports better decision-making for all patients.

Artificial intelligence is reshaping clinical research, but its impact extends far beyond automation. In this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Paulo Limgenco (VP, Business Operations at YPrime) and Michael Tucker (VP, Patient Experience - Commercial at Medidata) to explore how AI and digital technologies are helping the industry build more sustainable, efficient, and patient-centered clinical trials.From protocol optimization and site selection to localization and decentralized trial models, the conversation examines how AI can reduce operational burdens, minimize waste, and expand access to research opportunities for underrepresented populations. The discussion also highlights the importance of responsible AI adoption, including strong governance frameworks, data stewardship, and human oversight.Tune in for an insightful conversation on how the industry is balancing innovation and responsibility while working toward a future where clinical trials are more efficient, inclusive, and sustainable for patients, sites, sponsors, and communities worldwide.

What does it take to run successful clinical trials across borders? Tune in as Chris Boone (Group VP, Research, Health & Life Sciences at Oracle) and Alicia Baker McDowell (VP & Head of Global Regulatory Strategy at Fortrea) explore the shift from transactional outsourcing to truly co-created partnerships.They discuss how sponsors, CROs, and tech partners are redefining collaboration, tackling data fragmentation, and striking the right balance between global consistency and local execution to deliver more effective clinical trials worldwide.