Profil employs two research physicians with over 15 years of experience in ethno-bridging studies. In addition, we have Chinese- and Japanese-speaking research physicians, along with a native Japanese nursing staff that is involved in the performance of these trials.
Data from the Japanese clinical bridging studies 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. Profil is positive that the acceptance and approval of data from Chinese bridging studies will go equally well.
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.