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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.
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.
In this whitepaper, 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.
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