Exec. Feature: One of the Industry’s Top Risk-Based Quality Management Experts—Lisa Moneymaker


The topic of risk-based monitoring has frankly disappointed many over the last handful of years as the promise to sponsors and sites of remote, centralized monitoring based on actual risk involved to the study generated huge interest and promise. In theory, a compelling methodology to reduce 100% on site source data verification—and hence potentially dramatically reduce the cost to the clinical trial's sponsor—promised a dramatic transformation of research productivity, efficiency, and quality. A recent survey by the Association of Clinical Research Organizations reveals that there’s still a long way to go to achieve ubiquitous RBM. Meanwhile, the pandemic, which led to more decentralized research activity, unfortunately didn’t lead to a reduction in protocol deviations at the site level despite known RBM methods and rapidly evolving technology supporting decentralized studies. Enter Medidata executive Lisa Moneymaker, an expert in the field of what she refers to as risk-based quality management. With executive ownership of the Medidata RBQM suite, TrialSite recommends anyone interested in learning more to connect.

A consultant and subject matter expert, TrialSite interviewed M...

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