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Japanese Academic Research Center Deploys Medidata Rave

Medidata Solutions, a provider of hosted clinical development solutions to pharmaceutical, biotechnology and medical device companies, has reported that the Clinical Trial Coordinating Center (CTCC) of Japan-based Kitasato University Research Center for Clinical Pharmacology has chosen to standardize on Medidata Rave as its electronic data capture (EDC) and clinical data management (CDM) solution for its clinical trials.

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 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).

The Kitasato CTCC chose Medidata Rave based on the technology’s 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 implementation methodology, along with Rave’s built-in e-Learning 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.

Masahiro Takeuchi, director of clinical pharmacology at Kitasato University Research Center, said: “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.

“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.”

Tarek Sherif, CEO of Medidata Solutions, said: “Our relationship with the Kitasato CTCC is a result of Medidata Rave’s reputation in Japan as a trusted platform for helping organizations meet and surpass their clinical research goals. 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.”