Vaccine maker KAKETSUKEN, also known as the Chemo-Sero-Therapeutic Research Institute, has become the first Japanese pharmaceutical company to use the combined capabilities of the Medidata Balance™ randomization and trial supply management (RTSM) solution and Medidata Rave ® electronic data capture (EDC), clinical data management and reporting system for a Japanese clinical trial. A leading company in the field of biological products, KAKETSUKEN will use the Medidata Solutions (NASDAQ: MDSO) platform to reduce time, costs and risk in a Phase II clinical trial testing a vaccine, and plans to use the solutions for other future trials.
Based on Medidata’s strong global reputation and leading role in Japanese life sciences clinical development, including Japanese clinical sites’ preference for the instantly accessible, easy-to-use Rave system, KAKETSUKEN chose Medidata’s integrated solution to drive trial efficiencies and help it meet aggressive trial timelines. The unified RTSM-EDC solution enables investigators to interact with only one system—Medidata Rave—for EDC, randomization and supply management. As a result of this pre-validated solution, KAKETSUKEN has been able to more efficiently randomize patients to treatment arms, manage dispensation and collect and report on patient data, streamlining the end-to-end trial process. KAKETSUKEN used Balance, including its powerful simulation capabilities, to randomize more than 200 subjects across four sites and completed subject enrollment and randomization in half the anticipated time, successfully achieving its ambitious goals.
- “Medidata Rave and Balance as an integrated solution for randomization, dispensation and EDC are essential to our ability to meet aggressive trial deadlines with high-quality results that we promise our customers,” said Shinji Tochihara, deputy general manager, clinical development department, KAKETSUKEN. “In addition, an effective support team that understands our challenges and is willing to partner with us at every step makes a remarkable difference. Medidata offers us that full package.”
Medidata’s professional services staff worked closely with KAKETSUKEN to ensure a speedy implementation process, keeping the company on track with the trial timeline. The company also used Medidata’s integrated eLearning capabilities to get sites up and running quickly. Moreover, through the active Japan Medidata User Group (J-MUG), which includes representatives from more than 50 life science organizations, KAKETSUKEN can network with other leading regional research sponsors, learn best practices and maximize the effectiveness of the tools.
- “Medidata’s cloud-based platform is designed to bring efficiency improvements throughout the trial process, and offers additional benefits with the use of multiple integrated applications,” said Glen de Vries, president, Medidata Solutions. “The efficiencies seen by KAKETSUKEN – rapid trial start-up, easier user training and simplified site usage – will help ensure maximum trial quality and result in real benefit to patients.”
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