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 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. 

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 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.

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 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.

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.

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 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.

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, 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.