Medidata, a source for cloud-based solutions aimed at clinical research in life sciences, announced that Sanofi has increased its adoption of the Medidata Clinical Cloud as part of a company-wide initiative to achieve cutting-edge productivity across its global R&D organization.
Sanofi, a Medidata enterprise client, will now leverage Medidata’s technology for risk-based monitoring of clinical trial sites, in addition to the broad set of solutions and analytics already used through the Medidata platform to improve operational efficiencies, resource savings and decision making.
As essaying the role of 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, as per the announcement.
The company has conducted risk-based monitoring for the past several years and selected Medidata’s targeted source document verification 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,” alleged Glen de Vries, president of Medidata. Supplementing that – “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.”
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 per cent of a clinical trial budget can be required to cover site monitoring costs,” de Vries furthered. Adding that – “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.”