Special Episode: RBQM: A Case for Centralized Monitoring

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 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 

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.

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/

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.

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.

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. 

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. 

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.