Japanese Academic Research Center Selects Medidata Rave

Japanese Academic Research Center Selects Medidata Rave
Kitasato University Clinical Trial Coordinating Center Will Implement Medidata's EDC/CDM System as Enterprise-Wide Platform to Support Clinical Trials 

NEW YORK & TOKYO, Apr 12, 2010 (BUSINESS WIRE) -- Medidata Solutions, a leading global provider of hosted clinical development solutions, today announced that the Clinical Trial Coordinating Center (CTCC) of Japan-based Kitasato University Research Center for Clinical Pharmacology has chosen to standardize on Medidata Rave(R) as its electronic data capture (EDC) and clinical data management (CDM) solution for its clinical trials.

Founded in 2003 and located in Tokyo, the Kitasato CTCC supports a range of clinical trials mainly in oncology. The Kitasato University Research Center for Clinical Pharmacology is one of two clinical research centers in Japan that receive funding from the Japanese Ministry of Health to promote global clinical trials and research. The Kitasato CTCC maintains a database that manages the clinical trial data collected by approximately 120 clinical trial sites in the Japanese Gynecologic Oncology Group (JGOG). Kitasato University Division of Biostatistics also has an academic exchange program with Harvard University's Department of Biostatistics and hosts the annual Kitasato University--Harvard School of Public Health Symposium.

The Kitasato CTCC focuses on enhancing the efficiency of clinical studies through quality control of clinical data, evaluating projects for ethical and scientific validity and educating staff involved in the research. The center joins Medidata's global customer base as the first Japanese-based academic institution; Medidata Rave is already in wide use at commercial research enterprises in Japan and in a broad range of academic, government and other non-profit institutions worldwide.

The Kitasato CTCC chose Medidata Rave based on the technology's proven use in Japanese clinical trials over many years and Medidata's global expertise in complex oncology clinical trials sponsored by academic, industry and government researchers. Medidata's proven implementation methodology, along with Rave's built-in eLearning training modules in Japanese, will ensure quick and efficient study start-ups. Rave's flexibility to meet the requirements of the range of trial phases and its ability to be delivered as a fully hosted application were also factors in the Kitasato CTCC's decision.

"We expect that Medidata Rave will allow us to conduct trials faster and more accurately, and we will also benefit from the growing network of Rave-trained clinical investigators and research coordinators throughout Japan," said Masahiro Takeuchi, Sc.D., M.P.H., Director, Kitasato University Research Center for Clinical Pharmacology. "As we approach our pilot, we have already been impressed with Medidata's substantial and robust study start-up approach, which details a clear methodology, configuration procedures and best practices. We look forward to relying on this model internally moving forward."

Starting in early 2010, Kitasato will pilot two Rave studies and has another five studies planned for 2010 starts, primarily Phase II and III oncology studies of varying sizes, involving 10 to 150 sites and 40 to 1,000 subjects. Kitasato intends to standardize on Rave for all of its new clinical studies.

"Our relationship with the Kitasato CTCC is a result of Medidata Rave's excellent reputation in Japan as a trusted platform for helping organizations meet and surpass their clinical research goals," said Tarek Sherif, CEO, Medidata Solutions. "We are excited to participate in the important work being done by this well-regarded academic institution and look forward to helping them enhance their clinical research."

About Kitasato Clinical Trials Coordinating Center (CTCC)

It is the mission of Clinical Trials Coordinating Center (CTCC) of Kitasato University Research Center for Clinical Pharmacology to dedicate ourselves to the improvement of health and the medical development by striving to enhance the quality of clinical studies through:

(1) The clinical trial projects based on ethical condition and scientific validity,

(2) The quality control of clinical data, and

(3) The education for all staff members involved in the research.

About Medidata Solutions Worldwide

Medidata Solutions (www.mdsol.com) is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers' clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer(R)), investigator benchmarking and budgeting (Medidata Grants Manager(TM)), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor(TM)), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave(R)). Medidata's diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.

SOURCE: Medidata Solutions

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