White Paper

Modernizing Clinical Trial Oversight: The Path to Clinical Operations Excellence

With the rising complexity of clinical trial protocols, the increase in the types and volume of patient-centric data, and other external challenges, such as limits to on-site activities have brought renewed attention and interest to these approaches to Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM).

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.