In this episode, Bari Kowal, SVP and Head Clinical Development Operations and Portfolio Manager at Regeneron, talks about her career journey in clinical R&D, from her days as a CRA to her current role as an executive, and what it takes to go from supporting a handful of sites to execute research, to helping a large organization do so at scale. Bari reveals the importance of good site relationships at every level, and how smart technology can manage, understand, and correct the data collected at trials in real-time. She discusses complex dynamics of global site selection, development prioritization, and talent growth as big picture challenges that many researchers have the luxury of ignoring when they’re not an executive. Bari also shares her take on the nomenclature, economic value, and DEI factor of DCTs, explaining why they don’t really exist based on her experience. She states they are rather a makeup of variations on the protocols and types of sites implementing the trial, plus the technology being leveraged. Learn more about clinical research development operations by listening to this episode!
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Things You'll Learn
A CRA used to have a scope beyond data quality monitoring. They used to be highly sophisticated relationship managers, overseeing all aspects of a site: scientific, operational and financial.
A fully decentralized trial is an extremely rare model.
DCTs are currently very expensive, so real value can only be achieved if made easier and more affordable.
Great operational data analytics will help you manage research at scale
Technology can give us clues on performance in real time that manual paper based processes just cannot
Regeneron seeks people who inherently want to do the right thing and are vested in science and patients.
Picking the right sites and supporting them is everything
