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
- Now Competitive Trial Costs
- Highest Quality Standards Ability to Integrate Studies from FIH to POC within One Protocol
- No IND, pre-IND required for Phase 1 Studies
For more business opportunities with their global pharma /biotech sponsors, many CROs in the world are taking advantages of successful clinical study operations in Japan by partnering with reliable Japanese CROs, laying the groundwork for the current and future development of business opportunities now.
Because Japanese and Asian markets can be increasingly lucrative and attractive for western Pharma/ Biotech companies, it is strategically advantageous to perform early studies in Japan, getting faster and smoother access to both original and new markets simultaneously.
Also, there is a system called “In Country Clinical Care Takers (ICCCs)” in Japan for regulatory support, as well as a vast number of experienced global study monitors for clear communication and smooth study operations.(Essential Considerations for Requesting a Clinical Trial In-Country Representative
In Japan, we have 16 regular members and 21 associate members in the Japanese CRO Association. http://www.jcroa.or.jp/english/index.html
According to the association’s annual report for 2016 business, (http://www.jcroa.or.jp/english/pdf/2016report.pdf ), more than 92 % of their sales were from medical products followed by 2% for medical devices.
In detail, over 56% of these sales were for their monitoring services followed by DM/BioStat services (17.9%).
With regards to the monitoring projects by clinical phases, Phase 1 was 12.5%, Phase 2 was 23.4%, and Phase 3 was 45.2%, which showed similar ratios for Phase 1 and 3, and about a 6% increase for Phase 2 compared with 2015.
The TOP 5 therapeutic areas in 2016 were oncology, cardiovascular, metabolism, CNS, and allergy.
Japanese CROs are equipped with resources and experience, and are actively involved in working with foreign sponsors.
At SOUSEIKAI, using our network and experience, we are supporting global CROs who are interested in developing a system in preparation for their future study operation needs in Japan.
We are proud to be helping our global CRO partners obtain more economic benefits and quicker development turn-around for their sponsors in Japan and globally.