ACRO's Good Clinical Podcast

ACRO
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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 

  1. 06/23/2025

    S3: E10 Survey Says: Trends in Risk-Based Monitoring and Beyond

    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 adoption of RBM and RBQM components. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies’ adoption of risk-based monitoring to better understand how the larger framework of risk-based quality management (RBQM) are being adopted across the clinical trial industry.

    36 min

  2. 06/16/2025

    S3: E9 Granting Access to Research: Lessons from ACRO’s Site Grant Program

    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 (Randomize Now), and Sandra Carmona Torres, BSN (K2 Medical Research) join the podcast to discuss the lessons learned through implementing their pilot projects so far. They dive deeper into how sites can address barriers to participation, the need for consistent investment in building trust and engaging local community members, and the state of clinical research from a site perspective.

    26 min

  3. 06/10/2025

    S3: E8 AI on the Prize: How AI is Modernizing Clinical Operations

    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 clinical operations to expand access to trials and get treatments to patients sooner.

    32 min

  4. 06/03/2025

    S3: E7 The Impact of ICH E6(R3): Sponsor and CRO Perspectives

    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 experiences implementing the new guidance at their respective companies, the new opportunities that R3 has created in the partnership between CROs and sponsors, and how they envision the future state of R3 once industry has fully embraced the guidance. FIND ACRO & TRANSCELERATE'S ICH E6(R3) TOOLS & RESOURCES HERE: https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/

    26 min

  5. 05/27/2025

    S3: E6 From Protocol to Patient: Strategic Uses of AI in Today's Clinical Development

    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 analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

    39 min

  6. 05/20/2025

    S3: E5 Rethinking Rare: The Future of Rare Disease Research

    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 patients. They dive deeper into the evolution of rare disease patient advocacy groups, why industry must move beyond the hyperfocus on “blockbuster drugs” to make progress in rare disease research, and how advancements in rare disease treatments can benefit the clinical research ecosystem for all.

    27 min

  7. 05/13/2025

    S3: E4 Kernels of Wisdom: What Matters Most in Clinical Trial Monitoring

    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 the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

    42 min

  8. 05/06/2025

    S3: E3 Future-Proofing Drug Development: AI, Old Data, and New Rules

    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 into the role that collaboration between technologists and clinical scientists can play in helping to reduce bias in our AI models, what legislators and regulators should be keeping top of mind as they write new rules of the road for AI and ML, and ACRO’s ongoing efforts to promote the responsible use of AI in clinical research.

    33 min
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About

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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