Tokyo, Japan (PRWEB) March 9, 2011
Emergo Group, a leading medical device quality assurance and regulatory affairs consulting firm, has formed a strategic partnership with Data Pharma Co. Ltd. to provide full clinical trial management services in Japan. Data Pharma is the Clinical Research Organization (CRO) subsidiary of Tokyo-based NTT Data Group.
Emergo Group's office in Tokyo, Emergo Japan K.K., will offer comprehensive clinical trial management services to assist medical device manufacturers. The move comes in response to a growing need for medical device manufacturers to demonstrate the efficacy of their products through clinical trials conducted in Japan.
Michiharu Miyahara, President and CEO of Emergo Japan K.K. notes: "The Japanese government has a strategy to drive growth in the life sciences industry, but this has been challenging due to the complexity of conducting clinical trials in Japan which are sometimes needed to obtain regulatory approval. There are very few consultancies specializing in medical device clinical trials in Japan so we are addressing this growing need. Our team is eager to start helping manufacturers conduct clinical trials for their products prior to commercialization in Japan."
Japan's Pharmaceutical and Medical Devices Agency (PMDA) requires clinical trials in cases where a medical device's safety and efficacy cannot be evaluated using existing literature or non-clinical evidence, as well as for high-risk devices. The PMDA sometimes accepts clinical trial results obtained outside Japan, provided those results conform to the country's equivalency standards.
Emergo Japan and Data Pharma provide clinical trial management consulting and CRO-related services respectively for both foreign and Japanese medical device clients.
About Emergo Group
Emergo Group is a medical device regulatory consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distribution consulting. Emergo Group has more than 1500 clients manufacturing a wide range of medical devices and IVDs. Offices worldwide. http://www.emergogroup.com
About Data Pharma
Data Pharma, a member of NTT Data Group, is a contract research organization supporting more than 100 health care institutions across Japan. Supporting both medical device and pharmaceutical clinical trials, Data Pharma also offers data management and statistical analysis services.
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