Medidata, a leading global provider of cloud-based solutions for clinical research in life sciences, announced that its cloud-based technology platform has been adopted by JCR Pharmaceuticals Company Limited, a Japanese pioneer in biotherapeutics.

JCR Pharma is leveraging the Medidata Clinical Cloud to support research on a therapy for the treatment of Fabry disease, bringing greater speed and operational efficiencies to the organization’s development programme in Japan.

With a primary focus on biotherapeutics that use recombinant DNA (rDNA) technology to address significant unmet medical needs, JCR Pharmaceuticals is developing therapeutic enzymes to treat lysosomal storage diseases (including Fabry disease), a group of rare genetic diseases that occur in very small patient populations. For its clinical study on a Fabry disease treatment, JCR Pharmaceuticals has selected Medidata’s cloud-based technology for electronic data capture and management, Medidata Rave to streamline clinical trial operations.

“Fabry disease is an inherited and progressive condition, with approximately 5,000-10,000 diagnosed patients in the world and 300 in Japan alone,” said Hideaki Hirai, data science group manager, clinical intelligence department, development division, JCR Pharmaceuticals. “The broad adoption of Medidata’s cloud-based technology solutions, including Rave, across Japan allows us to be agile in our studies and efficient with our resources, while ensuring investigator engagement in our research efforts. We look forward to better data and faster trials—which our partnership with Medidata is enabling—and working together to quickly deliver a value-added treatment option to Fabry patients in need.”  

Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific region, said “With more and more sponsor companies adopting Medidata Rave for their clinical trials, investigators and CRCs (clinical research coordinators) are increasingly able to quickly and efficiently begin using the technology at sites across Japan. By incorporating the Medidata platform into its research programme, JCR is helping to modernize the field of rare and orphan disease drug development while ensuring investigative sites remain engaged. We’re proud to partner with such a forward-thinking organization and support its longstanding commitment to developing valuable treatment options for under-served patient communities around the world.”