Ethnobridging leadership

Begin With the End in Mind: Fast Track Drug Development in Asia

PAREXEL Early Phase are world leaders in the performance of ethnobridging studies. As inclusion of Asian countries in global drug development strategies and registration of drugs in the Asia Pacific region has become increasingly important in recent years PAREXEL has developed services to provide support right where you need it to help you collect Japanese, Chinese and Korean Phase I data early in development to fulfill your goals:

• Fast-track Japan development
• Facilitate Asian trials
• Facilitate the inclusion of Asian countries in global trials
• Use data for drug registration in the region

PAREXEL has significant experience in the performance of ethnobridging trials. In fact we have successfully conducted over 80 ethnobridging studies in Japanese, Chinese and Korean populations. We have enrolled more than 1,000 subjects into these trials.

Over the years, scientists at PAREXEL have worked closely with Asian regulators to design studies done outside of Asia but accepted by the Asian regulators. In fact, we defined the definition of a Japanese subject that is now widely used by the industry. Our experts are available to provide consultation on regulatory issues, protocol designs and analysis of data.