Modernizing Clinical Trial Oversight: The Path to Clinical Operations Excellence
The rising complexity of clinical trials and 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. With the increasing prevalence of decentralized clinical trials, the industry is now poised to fully embrace and implement risk-based quality management (RBQM) approaches to trial execution and oversight.
This white paper outlines the current state of RBQM in virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.
Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700 customers and partners access the world’s most-used platform for clinical development, commercial, and real-world data. For more information, visit www.medidata.com.