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The rising complexity of clinical trials, combined with pressures resulting from the COVID-19 pandemic, have 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. With the increasing prevalence of decentralized clinical trials (DCTs), the industry is now poised to fully embrace and implement risk-based quality management approaches to trial execution and oversight.
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 rising complexity of clinical trial protocols, the increase in the types and volume of patient-centric data, and the challenges of the COVID-19 pandemic – limits to on-site activities, in particular – have brought renewed attention and interest to these approaches. Now that risk-based 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.