ACRO's Good Clinical Podcast

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 refle...

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, effic...

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, tac...

Artificial intelligence is rapidly reshaping the landscape of rare disease research -- but how close are we to realizing its full potential? In this episode, Tanya Binette (Director of Therapeutic Expertise, Rare Disease at ICON plc) and Roz Round (SVP of Operational Strategy, Patient and Site Engagement at Precision for Medicine) explore how AI is being applied across the rare disease clinical tr...

Site feasibility remains a critical yet complex component of clinical trial startup. In this episode, listen as Andrea Bastek (VP, Market Strategy at Florence Healthcare), Christine Senn (SVP, Site-Sponsor Innovation at Advarra), and Ashley Davidson (SVP, Head of Product at Advarra) unpack the persistent challenges in feasibility -- from manual, time-intensive processes and data trust gaps to misa...

What does "patient-centricity" actually look like in practice, and why does it still fall short? In this episode, Stacy Hurt (Chief Patient Officer at Parexel) and Alicia Staley (Chief Patient Officer at Medidata) bring both lived experience and industry insight to a powerful discussion on the gaps between intention and reality in clinical research. They unpack the emotional and logistical challen...

What happens when clinical trial sites are given the resources and autonomy to determine precisely what their site needs to be successful? In this episode, participants from the ACRO Site Grants Program share how targeted funding helped them tackle real-world barriers to clinical trial access and diversity. From community-based outreach and patient education, to internal infrastructure and st...

Artificial intelligence is reshaping every stage of drug development, but unlocking its full potential requires more than technology alone. In this episode, Clay Alspach (Executive Director, ACRO) Raja Shankar (VP of Machine Learning at IQVIA), and Andrew Mackinnon (SVP & Executive General Manager at Medable) come together to examine how policy, regulation, and global collaboration will shape...

LINK TO ACRO'S RBQM SUMMARY REPORT: https://www.acrohealth.org/rbqm-summary-report/In this episode, ACRO RBQM Working Group members Lauren Garson (Veeva), Cris McDavid (Parexel), and Jennifer Stewart (Premier Research) joined ACRO’s Good Clinical Podcast to discuss key takeaways from ACRO's annual RBM/RBQM Landscape Survey. Since 2019, ACRO's RBQM survey has dug into trial-level data on industry a...

In 2024, ACRO announced its D&I Site Resource Grants Program. Designed to support an innovative 12-month pilot project, the site resource grants act as a platform to incubate innovative strategies for improving representative enrollment in clinical research.  On this episode, site grantee representatives Dr. Ammara Mushtaq, MD (Brooklyn Clinical Research), Dr. Lovie Negrin, APRN (Ran...

In this episode, Jonathan Norman (Director, Localisation Services, YPrime) and Laura Russell (Senior Vice President, Head of Data and AI Product Development, Advarra) join the podcast to discuss how artificial intelligence is transforming today’s clinical operations. They dive deeper into how AI can be used to improve protocol design, drive efficiency in localization processes, and modernize...

In the latest collaboration between ACRO and TransCelerate BioPharma, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. They dive deeper into their e...

Malaikannan Sankarasubbu (Chief Technology & AI Officer, Saama) and Jonathan Shough (Chief Information Officer, Parexel) join this week’s episode to discuss how the strategic use of AI technologies is transforming clinical development. They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive a...

On this episode, Tania Simoncelli (Vice President, Translational Impact and Engagement, Chan Zuckerberg Initiative) and Nasha Fitter (Co-founder & CBO, Citizen Health and Co-founder & CEO, FOXG1 Research Foundation) join forces to discuss how rare disease patient advocacy has transformed over time and how the biopharmaceutical industry should adapt to better meet the needs of today’s patie...

What does clinical trial monitoring have in common with growing a field of corn? Amy Kroeplin (PPD™ clinical research business of Thermo Fisher Scientific), Shailesh Madel (ICON plc), and Nicole Stansbury (Premier Research) join the podcast to discuss the importance of risk-based quality management, centralized monitoring, and strategic SDV/SDR sampling strategies. They dive deeper into...

On this week’s episode, Lisa Moneymaker (SVP, Head of Strategic Customer Engagement, Medidata Solutions) and Adam Aten (Legislative & Regulatory Policy Lead, Verily) join the podcast to discuss how the clinical research industry must use insights from the past to better prepare our AI models and other technologies to meet the needs of patients in the present and future. They dive deeper i...

On this week’s episode, host Sophia McLeod is joined by Danilo Branco (Associate Director, Risk Based Quality Management Lead, BeOne Medicines) and Amanda Coogan (Associate Director, Customer Experience, Remarque Systems) to discuss the value of centralized monitoring implementation by sharing case studies from today’s clinical trials. They dive deeper into how centralized monitoring can help...

ACRO’s Good Clinical Podcast is back for season 3! To kick off the season, host Sophia McLeod is joined by Clare Campbell-Cooper (Global Head, Digital Health and Innovation, Fortrea) and Michael J. Cohen (Sr. Director, Lead, Environmental Sustainability, PPD™ clinical research business of Thermo Fisher Scientific) to discuss the continued evolution of environmental sustainability in clinical resea...

On this special episode of ACRO’s Good Clinical Podcast, 2025 ACRO Chair Jim Reilly (Veeva) and Vice-Chair Sandy Kennedy (Fortrea) join the podcast to discuss the current state of the clinical research ecosystem and where our industry should focus attention to continue moving research forward in 2025.They dive deeper into the challenges and opportunities in making clinical research more accessible...

This week, ACRO’s Good Clinical Podcast returns for a special episode! Lauren Garson (Veeva), Nicole Stansbury (Premier Research) and Jennifer Stewart (Premier Research) join the podcast to discuss the ACRO RBQM Working Group’s latest paper, “Risk-based Quality Management: A Case for Centralized Monitoring," available to download at https://www.acrohealth.org/resource/rbqm-centralized-monitoring/T...

On the season 2 finale of ACRO’s Good Clinical Podcast, Steve Cutler (CEO, ICON plc) and Professor Lucy Chappell (CEO, NIHR) join the podcast to discuss the current clinical research landscape in the UK.They dive deeper into the competitive nature of bringing clinical research to a country, process-related challenges that need to be addressed in order to realize the benefits of AI and other techno...

On this episode, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical Research Business of Thermo Fisher Scientific) join the podcast to discuss insights from 5 years of data on industry RBM/RBQM adoption collected by ACRO’s RBQM Worki...

On this episode, Susan McCune, MD (VP, Pediatrics & Clinical Pharmacology, The PPD Clinical Research Business of Thermo Fisher Scientific) and Jacqui Whiteway, PhD (Senior Director & Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON plc) join the podcast to discuss what makes pediatric clinical trials unique and how industry can make participation easier for pedia...

On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to talk about ACRO’s collaboration with TransCelerate BioPharma, Inc. and to discuss impact that ICH E6(R3) will have on Good Clinical Practice and implications for innovation. They dive deeper i...

On this episode, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research. They dive deeper into the FDA’s evidentiary standards for AI, what organizations should co...