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As a founding member of TransCelerate BioPharma Inc. —a non-profit organization dedicated to improving the health of people worldwide by accelerating and simplifying the R&D of innovative new therapies through industry collaboration—Sanofi is engaged in developing an industry-wide approach for targeted monitoring of clinical trial sites to enhance productivity while protecting patient safety and data quality. The company has conducted risk-based monitoring for the past several years and selected Medidata’s targeted source document verification (Medidata Rave® TSDV) capability to provide an efficient, scalable and auditable technology solution for its clinical operations and data management teams.
―We’re proud that Medidata’s cloud-based platform is supporting Sanofi in driving the effective and high-quality delivery of new medicines to patients worldwide,‖ said Glen de Vries, president of Medidata. ―Sanofi is an early adopter of risk-based monitoring practices and has been quick to implement TransCelerate’s recommendations on this important methodology, streamlining the way clinical trials are conducted and monitored around the world.‖
In 2012, Sanofi adopted Medidata’s cloud-based technology for electronic data capture and management (EDC), safety data collection, medical coding, clinical business analytics and industry benchmarks. The addition of Rave TSDV—the solution unified with Medidata’s technology platform to support risk-based monitoring—provides Sanofi’s research teams with flexible tools that reduce timelines, increase productivity and provide quick access to meaningful data. ―Today, more than 30 percent of a clinical trial budget can be required to cover site monitoring costs,‖ de Vries added. ―By supporting the implementation of a risk-based approach to site monitoring that more effectively targets identifiable risks,
Medidata's platform can help reduce the resource requirements for sponsors, CROs, and the doctors and nurses collaborating on a study, without compromising the quality or data integrity, and ultimately streamlining how life-enhancing treatments get into the hands of patients.