Emergo Group, NTT to Provide Full Clinical Trial Support in Japan

February 7, 2011 - Emergo Group, a leading medical device quality assurance and regulatory affairs consulting firm, has formed a strategic partnership with Tokyo-based IT product and service provider NTT Data Group’s clinical research organization (CRO) subsidiary Data Pharma Co., Ltd. to provide full clinical trial management services in Japan.

Emergo Group’s Japanese unit Emergo Japan K.K. and Data Pharma will offer a Comprehensive Clinical Trial Management Service in order to address the Japanese government’s strategy to drive growth in the life sciences industry. The service was developed to assist medical device manufacturers in dealing with high costs of conducting clinical trials for their products prior to commercialization.

The two firms will jointly implement clinical development support services for both foreign and domestic medical device clients. Emergo Group and Data Pharma will provide clinical trial management consulting and CRO-related services, respectively.

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 often accepts clinical trial results obtained outside Japan, provided those results conform to the country’s equivalency standards.

About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. 

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 pharmaceutical and medical device clinical trials, Data Pharma also offers data management and statistical analysis services.