souseikai global clinical research center

For CROs

Japanese CROs are equipped with vast resources and experience, and actively involve themselves in working with foreign CROs.

Japan has been reconsidered and revisited as a location for early studies in recent years.

The reasons for this trend are:

  • A New and Improved Japanese Regulatory System
  • The Rediscovery of Japan by the Industry as a High-potential Market
  • Competitive Trial Costs
  • Ability to Integrate Studies from FIH to POC within One Protocol
  • No IND, pre-IND required for Phase 1 studies

Chart: Number of early studies conducted in Japan

For more business opportunities with global pharma/biotech sponsors, many CROs in the world are laying the groundwork for current and future development of business opportunities now, by partnering with reliable and consistently successful Japanese CROs, and thus taking advantages of successful clinical study operations in Japan.

Because Japanese and Asian markets can be increasingly lucrative and attractive for Western pharma/biotech, it is strategically advantageous to perform early studies in Japan. This allows for faster and smoother access to both original and new Asian markets simultaneously.

In Japan, we have 15 regular members and 32 associate members in the Japanese CRO Association.

According to the association's annual report for 2019 business, (, 88.8 % of their sales were from medical products followed by 2.6% for medical devices.

At SOUSEIKAI, using our network and experience, we are supporting foreign CROs which are interested in developing a system in preparation for their future study operation needs in Japan. If you are interested in Japanese CRO referrals for a potential collaboration/partnership, please feel free to contact us.

We have pride in being able to help foreign CROs obtain a quicker development turn-around as well as economic benefits for their sponsors in Japan and globally.