Advertise on podcast: ACRO's Good Clinical Podcast

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.  

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.

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. 

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/ 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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