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Astellas Selects Medidata Solutions Trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Astellas Pharma, Inc. has chosen Medidata Solutions Rave 5.5 as its standard global solution for all clinical studies in Phases I-III during the next five years. Astellas plans to implement clinical trials using Medidata Rave 5.5 across North America, Asia, Europe and other regions.

According to the company, the selection was based on Medidata’s understanding of the requirements of the global clinical development process and its reliable and secure hosting and help desk services and support. Medidata Rave 5.5 is able to support Astellas’ global initiatives on a single scalable platform by offering the flexibility to allow clinicians to 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. “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 translation procedures and allow users to work in their native language against a single, global, centrally-managed repository of clinical data.

“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, chief executive officer 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, and we look forward to collaborating with the Astellas team as they standardize their global clinical trial procedures using Rave.”

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