Medidata Introduces Regulated Content and Document Management Capabilities

Medidata announced the availability of its regulated content management (RCM) platform, Medidata RCM.

In collaborating with Box, Medidata has expanded the Medidata Clinical Cloud to include products for standard operating procedure (SOP) management and electronic trial master file (eTMF) archive. These solutions provide customers the ability to manage all content, data and workflows in a single, integrated platform that meets the most rigorous usability, scalability, performance, compliance and security requirements.

Medidata’s solution is designed to focus on the most important aspect of advancing clinical innovation, the user, by empowering key R&D players—sponsors, sites and contract research organizations (CROs)—to seamlessly manage regulated content in a single, unified platform.

“Medidata RCM improves the most crucial elements of working with regulated content in the clinical development space,” Medidata’s chief operating officer, Mike Capone said. “Built with incredibly intuitive workflows and accessible from anywhere at any time, Medidata RCM supports our customers in complying with their legal and regulatory requirements, while making content management and version control easier. This streamlined environment is a major milestone for our industry, as we provide the holistic technology infrastructure for sponsors, sites and CROs to extract and share data in real time, and ultimately advance scientific discovery for patients in need.”

Medidata RCM is a fully-validated 21 CFR, Part 11 and Part 820-compliant system that delivers patent-pending live content integrity technology that actively ensures inspection readiness for life sciences companies.

"We are delighted that Medidata is leveraging our cloud content management platform to break new ground in offering the life sciences industry the ability to manage regulated and nonregulated content in one single solution," Jeetu Patel, CSO and SVP of Box said. "This approach gives the industry the ability to improve collaboration and efficiency by consolidating all documents and workflows into one place.”

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