ACRO's Good Clinical Podcast

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Welcome to ACRO’s Good Clinical Podcast, where we take a look at the current state of clinical research and what direction the industry must head in to continue improving trials for patients. Host Sophia McLeod is joined by industry leaders to discuss the latest industry trends, cutting-edge innovation, and reflect on the state of clinical research today based on the lessons learned from yesterday. Covering topics like women in clinical research and how AI can be responsibly integrated into the industry, the Good Clinical Podcast offers perspectives from leaders and innovators from across the industry. 

ACRO


    • Jun 3, 2025 LATEST EPISODE
    • every other week NEW EPISODES
    • 33m AVG DURATION
    • 21 EPISODES


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    Latest episodes from ACRO's Good Clinical Podcast

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

    Play Episode Listen Later Jun 3, 2025 26:11


    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/ 

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

    Play Episode Listen Later May 27, 2025 38:56


    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.

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

    Play Episode Listen Later May 20, 2025 26:56


    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.

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

    Play Episode Listen Later May 13, 2025 41:54


    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.

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

    Play Episode Listen Later May 6, 2025 33:10


    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.

    S3: E2 Centralized Monitoring in Action: Case Studies From the Field

    Play Episode Listen Later Apr 29, 2025 21:46


    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 detect adverse events more quickly and identify underreporting, the benefits of holistically monitoring trial data using centralized monitoring, and how a targeted SDV/SDR sampling strategy can help organizations to conserve resources while maintaining quality and safety.

    S3: E1 Minimizing Impact, Maximizing Progress: Environmental Sustainability in Research

    Play Episode Listen Later Apr 22, 2025 28:55


    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 research. They dive deeper into how the clinical research industry can use renewable energy to help meet environmental goals, the importance of promoting more environmentally sustainable shipping and logistics practices, and how our industry can decentralize trial elements responsibly to minimize the environmental impact of the clinical supply chain.

    Special Episode: 2025 State of the Industry

    Play Episode Listen Later Mar 11, 2025 28:17


    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 globally, the benefits of standardization in research, how our industry relationship with sites must evolve, and the positive impact that more representative trials have on data quality.

    Special Episode: RBQM: A Case for Centralized Monitoring

    Play Episode Listen Later Jan 14, 2025 21:46


    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/They dive deeper into highlights from their latest publication, including the benefits of a risk-based approach to trial monitoring and the role that centralized monitoring can play in building more efficient and effective clinical trials.

    S2: E6 The State of Clinical Trials in the UK: 2024 Update

    Play Episode Listen Later Aug 13, 2024 31:34


    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 technologies, and importance of bi-directional communication between CROs and government.

    S2: E5 RBQM: Moving Beyond a Belt and Suspenders Approach to Data Quality

    Play Episode Listen Later Jul 30, 2024 28:50


    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 Working Group has and how industry can drive further RBQM adoption.They dive deeper into ACRO's annual RBQM landscape survey findings, challenges and opportunities presented by the growth of centralized monitoring and reduced SDR/SDV, and the role that RBQM can play in the future of clinical research.

    S2: E4 Pediatric Clinical Trials: Compassion in Action

    Play Episode Listen Later Jul 23, 2024 39:18


    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 pediatric patients and their families.They dive deeper into the role that compassion plays in designing successful trials, the importance of including pediatric patients and families in trial protocol design, and creative tools to boost patient engagement

    S2: E3 ICH E6(R3): The Thinking Person's GCP

    Play Episode Listen Later Jul 16, 2024 24:24


    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 into the benefits of a risk-based approach, regulator's thoughts making clinical research more agile, and the potential to help industry bring medicines to patients more efficiently.

    S2: E2 AI in Clinical Research: Decoding Regulatory Expectations

    Play Episode Listen Later Jul 9, 2024 43:05


    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 consider about methodological transparency in submissions, and AI's potential as a tool that can help bring medicines to market more efficiently.For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/

    S2: E1 "All Hands on Deck" for Empathetic Patient Centricity

    Play Episode Listen Later Jul 2, 2024 43:29


    ACRO's Good Clinical Podcast is back! This week, Stacy Hurt, Chief Patient Officer at Parexel, and Alicia Staley, Vice President, Patient Engagement at Medidata joined the podcast to discuss how we can turn patient centricity from “buzz words” to action. They discuss how their own experiences as patients have informed their approach to clinical research and the important role that an upstream patient voice plays in reducing the burden on patients.

    Fast Facts: ACRO D&I Grants Program

    Play Episode Listen Later May 21, 2024 20:04


    ACRO's Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristin Surdam (ACRO D&I Steering Committee Member) to discuss ACRO's new D&I Site Resource Grants Program. They provide background on the goals of the program and what sites need to know when applying for grants.

    Women in Clinical Research (Part 2)

    Play Episode Listen Later Oct 30, 2023 35:17


    On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod is joined by Cyndi Verst (President, R&DS Design & Delivery Innovation, IQVIA) and Peyton Howell (Chief Operating & Growth Officer, Parexel). Peyton and Cyndi sat down to discuss the changes they have seen in the representation of women in clinical research throughout their careers, from trial participation to the board room. They dive deeper into how the clinical research industry can make trials more accessible for women and the role that many women play as healthcare decisionmakers in their families.

    Diversity and Inclusion in Clinical Trials: Driving Sustainable Change

    Play Episode Listen Later Oct 23, 2023 42:25


    On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod sat down with Kimberly Richardson (Patient Advocate & Founder, Black Cancer Collaborative) to talk about what is still missing from conversations about diversity, equity, and inclusion in drug development. Kimberly shares her own experiences as a patient and a patient advocate, and how that has impacted her approach to diversity in clinical research.

    AI and ML in Clinical Trials: Challenges and Opportunities

    Play Episode Listen Later Oct 16, 2023 44:37


    On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod is joined by Lisa Moneymaker (Chief Technology Officer & Chief Product Officer, Saama Technologies) and Stephen Pyke (Chief Digital & Data Officer, EVP Clinical Data & Digital Services, Parexel). Lisa and Stephen dive into how AI and ML are currently being used in the clinical research industry and opportunities for further utilization in the future. They discuss misconceptions about AI and how regulators and policymakers are responding to its potential use in drug development.

    The State of Clinical Trials in the UK

    Play Episode Listen Later Oct 9, 2023 55:01


    On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod is joined by Lord James O'Shaughnessy (Co-Founder & Senior Partner, Newmarket Strategy), Alistair MacDonald (Operating Partner, GHO Capital Partners), and Leona Fitzgerald (Executive Director, Regulatory Affairs, PPD, part of Thermo Fisher Scientific). Building off Lord O'Shaughnessy's Report on Clinical Trials in the UK, listen to their discussion about approval timelines, implementation, governmental response, and where we must go from here.

    Women in Clinical Research (Part 1)

    Play Episode Listen Later Sep 20, 2023 32:14


    On this episode of ACRO's Good Clinical Podcast, host Sophia McLeod of ACRO is joined by Jackie Kent (Executive Industry Advisor) and Catherine Gregor (Chief Clinical Trial Officer at Florence Healthcare). They sat down to discuss their own experiences as women working in the clinical research industry and areas in which the industry needs to continue to grow to better promote representation. Catherine and Jackie dive into what the industry must do to make participating in clinical trials more accessible for all women.

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