The COVID-19 pandemic forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity. If the benefits of this shift are to last, the industry must fully embrace and implement risk-based quality management approaches to trial virtualization strategies.
Despite a decade’s worth of industry dialogue and widespread regulatory acceptance, Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) have not been widely adopted by clinical trial sponsors and CROs. But the acute challenges of the COVID-19 pandemic—limits to on-site activities, in particular—forced their hands in 2020. Now that riskbased approaches to clinical trial oversight are of greater importance, it is time to renew the conversation around RBQM. Many sponsors and CROs recognized operational efficiencies and improvements in trial execution as a result of the risk-based approaches they took in 2020, and these benefits could continue to accrue long after the pandemic is over. In this paper, Medidata outlines the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.