Abstract

Changes in the regulatoryenvironment and external factors, such as the recent COVID-19 pandemic, haveforced pharmaceutical companies and Clinical Research Organizations tore-evaluate how they engage with and support investigator sites. This paperdescribes using AI (Artificial Intelligence) based algorithms to model investigatorsite performance and create predictive analytics for workload and risks coupledwith key risk and performance indicators for clinical research professionals atSponsor. It describes how clinical operations can move to an operating modelbased upon dynamic approaches for monitoring studies and participating sites. 

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