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 Ms. Moneymaker and her knowledge was so impressive, she’s profiled here today. A well-rounded dynamic yet grounded personality, TrialSite’s founder Daniel O’Connor, an expert in eClincial technologies, shared, “frankly, it’s rare to encounter someone with this amount of industry depth combing both high-level executive vision coupled with strategy on the one hand, with a hands-on execution pedigree on other hand. Quite impressive.” TrialSite notes that our executive profiles aren’t paid for—only compelling executives that meet a high standard of excellence are included.
Moneymaker attended the University of Southern California, earning a Biomedical Biochemical Engineering degree then going on to establish a consulting career at Accenture. She moved into life sciences serving both biotech and medical device and diagnostic firms, ultimately making it to the apex industry consortium of TransCelerate BioPharma, where she helped develop the investigational registry solution, then moving to product lead on the Shared Investigator Platform. There she worked with well-known, highly-respected industry executive Jackie Kent and moved to Medidata, a Dassault Systemes company.
Lisa has accumulated tremendous experience, knowledge, and know-how in the domain of risk-based quality management that’s now harnessed at Medidata for the development of the Risk-Based Quality Management (RBQM) suite, a holistic group of solutions designed to streamline the adoption of proactive clinical operations oversight activities. This technology allows Medidata to provide sponsors and CROs with the capabilities they need in their clinical operations toolbox, and give sites and patients the support they need. Her team is seeing continued success with the RBQM suite, with the goal of helping CROs and sites create efficiencies and prioritize patient safety, while the sponsors can invest in innovative solutions for worldwide health and streamline time to market.
Industry Executive to Watch
Lisa Moneymaker, SVP—Clinical Operations Technologies
Call to Action: TrialSite recommends any industry sponsors or academic medical centers/trial site organizations seeking to learn more about holistic approaches to risk-based monitoring, consider contacting Ms. Moneymaker to learn more about the subject. Also, learn more about Ms. Moneymaker’s product suite here.