A Japanese pharma, Astellas, chose Medidata Solutions for all of its electronic data capture (EDC) needs in trials in Asia, North America and Europe.  Astellas is the successor firm to two earlier Japanese concerns, Fujisawa Pharmaceutical and Yamanouchi Pharmaceutical.

The contract may not be a large one for an EDC vendor working with a variety of major firms (Bayer among them), but it suggests that the competitive lead of rival Phase Forward in Japan is not insurmountable.

The press release notes that Astellas selected Medidata for the company’s understanding of the distinct requirements of the global clinical development process and its reliable and secure hosting and help desk services and support. Astellas felt Medidata Rave 5.5 could let clinicians capture, manage and report on clinical data simultaneously in the languages of their choice, including support for complete Japanese character sets.

“We were impressed with Medidata’s plan in the Japanese market and the company’s unique ability to manage paper trials as well as electronic trials,” said Mitsutoshi Mukai, vice president of data science at Astellas Pharma Inc. “With a reliable, scalable and user-friendly technology, Medidata is able to handle our diverse profile of global trials and allow us to focus on our core business of designing clinical programs.”

Rave 5.5’s Double Data Entry (DDE) feature will allow Astellas to collect both paper and electronic data in a single database, which provides global access for collaboration and monitoring of activities across various organizations and geographies. Rave 5.5’s Local Language Translation Workbench will also eliminate costly and time-consuming translation procedures. Unlike other platforms, Rave allows users to work in their native language against a single, global, centrally-managed repository of clinical data without requiring the installation of unique language software versions.

“We are deeply honored for Medidata Rave to have been chosen as Astellas’ electronic clinical data management solution, and share in their vision for streamlining a wide range of clinical trials. This relationship further highlights our success and commitment to delivering outstanding levels of service, quality and reliability,” said Tarek Sherif, CEO of Medidata Solutions. “Medidata’s infrastructure was built to flexibly and cost-effectively scale up or down to manage trials of any size within a company’s portfolio. We look forward to collaborating with the Astellas team as they standardize their global clinical trial procedures using Rave.”

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