Full support for your Japanese bridging study
Since 2005, Profil has been able to successfully complete clinical bridging studies involving over 200 healthy Japanese subjects. Importantly, all of our studies have been completed within the agreed timeline. Our database contains 300 volunteers holding a Japanese passport with Japanese parents and grandparents and can easily be extended should the need arise.
Profil employs two research physicians with over 15 years of experience in ethno-bridging studies. In addition, we have a Japanese-speaking research physician and a native Japanese nursing staff that is involved in the performance of these trials.
Data from these types of clinical bridging study performed at Profil have already been used for NDAs in Japan. The acceptance of our data by Japanese authorities considerably accelerated the approval process. In fact, according to a publication from the Japanese regulatory agency, approval times could be decreased from 56 months to 32 months using an ethno-bridging strategy. Considering the local concerns over the length of the Japanese approval process, this is a truly significant improvement.
The international contiguity of Profil offers opportunities for ethno-bridging studies with other Asian populations as well. Contact us to learn more about our capabilities to support your ethno-bridging study needs.