Emergo Group and Datapharm have partnered to set up a medical device-focused clinical trial service in Japan to cater for growing industry demand.

The new entity, which will be based in Emergo’s offices in Tokyo, will provide trial management and consulting services designed to help device manufacturers navigate the unique challenges of Japan’s complex regulatory environment.

One of the major challenges is that Japan’s Pharmaceutical and Medical Devices Agency (PMDA) frequently requires device manufacturers prove the efficacy and safety of their products via trials conducted in Japan.

Emergo CEO Michiharu Miyahara said, “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.”