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ACRO's Good Clinical Podcast: Daily Summaries Delivered
by ACRO
ACRO’s Good Clinical Podcast dives into topics vital to driving innovation in clinical research, from AI and other cutting-edge technology to regulatory topics that impact clinical trials around the world. ACRO's Sophia McLeod is joined by leaders from across the drug development industry to discuss the latest trends and what direction the industry must head to continue improving trials for patients
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- 3 days ago22 min
S5: E5 Beyond Complexity: Designing Better Oncology Clinical Trials
As precision medicine advances and oncology therapies become increasingly complex, are clinical trials evolving fast enough to keep pace and are we making them too burdensome for the patients they are designed to serve?In this episode of ACRO’s Good Clinical Podcast, host Sophia McLeod is joined by Angela Fix and David Cohan to explore how the industry can rethink oncology clinical trial design, improve patient access, and translate scientific advances into more effective and efficient research.The conversation examines the role of artificial intelligence in patient identification, protocol design, and data analysis; the potential of decentralized and hybrid approaches to bring trials closer to patients; and the importance of simplifying trial requirements while maintaining patient safety and data quality. The discussion also highlights persistent operational challenges, including biomarker-driven enrollment and the manufacturing and supply chain demands of increasingly complex therapies.Looking ahead, the guests consider how AI, broader care networks, and emerging treatments such as tumor vaccines could reshape oncology clinical trials over the next five years.
- 1 weeks ago37 min
S5: E4 Cybersecurity is Patient Safety: Protecting the Future of Clinical Trials
As clinical trials become increasingly digital and interconnected, cybersecurity is critical to protecting data integrity, maintaining trial continuity, and safeguarding patient safety. In this episode of ACRO’s Good Clinical Podcast, Sophia McLeod is joined by cybersecurity leaders Nelly Nauman (Parexel), Mick Ryan (ICON), and Charley Newberry (Syneos) to explore the evolving cyber threat landscape facing clinical research.In this episode, they discuss emerging cybersecurity risks, including AI, ransomware, third-party vulnerabilities, and decentralized trials. Speakers shared their experience and strategies for strengthening cyber resilience, protecting data integrity, and fostering industry collaboration to safeguard clinical research.They also shared perspectives on emerging security challenges and why cybersecurity, data trust, and patient safety must be built into clinical trial design from day one.
- 2 weeks ago27 min
S5: E3 AI Agents at Work: Connecting the Clinical Trial Ecosystem
Collaboration is at the core of connecting the clinical research ecosystem without adding to the technology burden for sites. The ongoing partnership between Advarra and ICON offers a practical example of what this can look like.In Good Clinical Podcast Season 5, Episode 3, Mike Eckrote (Advarra) and Travis Caudill (ICON) discuss how their collaboration is helping move toward an ecosystem where organizations and sites can continue using the tools that best meet their needs, while enabling information to flow seamlessly across systems and organizational boundaries.They explore the potential to reduce administrative complexity, improve interoperability, strengthen site efficiency, and keep humans at the center of critical decisions, ultimately creating more time and capacity for what matters most: patients.
- 3 weeks ago37 min
S5: E2 The Future of Early-Stage Trials: Speed, Safety, and Innovation
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.
- Oct 13, 202639 min
The Journey of RBQM & AI for Trial Monitoring: Where We Are
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.
- Jun 22, 202625 min
S4: E8 Moving from Awareness to Execution in Trial Representation
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.
- Jun 15, 202636 min
S4: E7 Advancing Sustainability Through Smarter Clinical Trial Design
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.
- Jun 8, 202628 min
S4: E6 Collaborating to Drive Global Progress in Clinical Research
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.
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About ACRO's Good Clinical Podcast
ACRO’s Good Clinical Podcast dives into topics vital to driving innovation in clinical research, from AI and other cutting-edge technology to regulatory topics that impact clinical trials around the world. ACRO's Sophia McLeod is joined by leaders from across the drug development industry to discuss the latest trends and what direction the industry must head to continue improving trials for patients
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