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Clinical Trial Optimization Podcast

RBQM in Clinical Research with Cyntegrity’s Artem Andrianov and Johann Proeve and Linda Sullivan


Is there a common set of key risk indicators (KRIs) the clinical trials industry is monitoring to achieve world-class Risk-Based Quality Management (RBQM)? That’s one of the key issues explored during Linda Sullivan’s interview with two returning CTO guests: Artem Andrianov, CEO of Cyntegrity and Johann Proeve, Chief Scientific Officer at Cyntegrity. Andrianov and Proeve note that they do see a set of “golden” KRIs – a subset of KRIs that many of their customers are monitoring with their RBQM system. When asked by Sullivan, Executive Director of WCG’s Metric Champion Consortium, about the impact of COVID-19, both guests say that there has been huge demand for implementation and training of their RBQM platform. They specifically advise clients to begin with pilot programs when implementing RBQM. A successful strategy for illustrating the value of using a RBQM system is to conduct a retrospective analysis of a completed study to determine how early emerging issues could have been identified compared to when (or if) the issues were identified using traditional monitoring approaches. The bottom line, according to the Cyntegrity officials: RBQM is a platform that enables sponsors to identify data or process problems early on, track them proactively and avoid late surprises. And, yes, they add, it’s vital that the persons reviewing the RBQM data are capable of interpreting that data and are able to implement appropriate remedial measures.

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