Podcast - How new trial designs and the pandemic have altered Risk-Based Monitoring

How new trial designs and the pandemic have altered Risk-Based Monitoring

How are organizations now tracking and assessing risk with risk-based quality management (RBQM) systems in the wake of new clinical trial designs and the COVDI-19 pandemic? That’s one the key questions explored during Linda Sullivan’s interview with Duncan Hall, CEO and Founder at TRI — The Risk-Based Monitoring Company, which specializes in making RBQM simpler and more accessible. Duncan, who appeared on CTO Episode #4 (August 2020), discusses how RBQM has been transformed and become more utilized in the last two decades, how the pandemic accelerated further RBQM changes, and how accompanying key risk indicator metrics have evolved as well. Duncan notes that, the pandemic forced clinical trial managers to accelerate plans to implement RBQM through centralized monitoring. He also discusses how the broader adoption of DCT modalities, including the increasing use of wearables, will impact the design and implementation of risk-based monitoring.

SUMMARY KEYWORDS
data, clinical research, pandemic, patient, qm, starting, site, technology, bit, companies, rbqm, monitoring, people, trial, industry, edc, happening, thinking, studies

LINDA SULLIVAN:
There are more than 344,000 clinical trials in the US and across the globe. These clinical trials are all different of course, but they have one goal in common to bring lifesaving therapies to patients in need. Welcome to Episode 39 of CTO to clinical trial optimization podcast. CTO is a twice monthly podcast that brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how we oversee, manage and optimize clinical trial planning and execution. The podcast includes discussions with clinical research, thought leaders and practitioners about how the industry is transforming clinical research, design and operations to speed up the delivery of life changing therapies.
I'm your host, Linda Solomon. And I want to thank you for joining me on this exciting journey to raise the bar on clinical trials and provide an interactive forum for discussing what we do professionally every day. We hope you'll subscribe to CTO on your favorite podcast platform, so you'll automatically get every episode in your feed for free. In this episode, we'll be exploring how new trial designs in the pandemic have changed what organizations are tracking and assessing in risk-based monitoring programs.

I'm joined today by Duncan Hall, CEO and founder of PRI, the risk-based monitoring company, Duncan has more than 25 years of experience in the life sciences industry. And during that time, his core focus has been on business process optimization, and the implementation of clinical systems to automate and drive efficiency in clinical trials. Duncan founded PRI in 2013, to specifically focus on the challenges of RBQM adoption, and has built an organisation which specializes in making RBQM simple and accessible for all organizations, no matter how large or small. Duncan was a podcast guest in Episode Four recorded in August of 2020. So welcome back to CTO, Duncan.

DUNCAN HALL:
Thank you, Linda. Great to be here. Again, thanks for having me back.

LINDA SULLIVAN:
So for those that were that didn't listen to episode four, let's give you let's give you a chance to give a little bit of background. So we can put it into context for the rest of the conversation. So tell us a little bit about yourself and how you got into clinical research...