First in Human Studies
We take pride in our FIH Studies!
Drug discovery and R&D have long been established as one of Japan's main industry strengths as can be seen from the many global pharmaceutical companies started in Japan, as well as more than 350 drug discovery companies now based in Japan.
Being driven by science, the progressive history of drug discovery in Japan, and the PMDA’s open minded support, SOUSEIKAI has successfully conducted more than 130 FIH studies in the last 25 years alone.
In Japan, FIH studies and Phase 1 studies are conducted at clinical research sites and evaluated by the sponsors’ assessment methods, not a national accreditation system.
Specific Considerations for FIH Studies:
- PI selection based on FIH study experience and specialty areas
- Precise and Thorough Care on Dosing days
- Advanced Emergency care protocols put in place
- Annual ACLS & BLS trainings for all staff by in-house AHA providers
- Quick access to SOUSEIKAI hospitals or nearby emergency hospitals
FIH protocols have evolved in recent years to shorten timelines while assuring the safety of subjects, and investigating essential parameters at early stages. If you are interested in any integrated combination study designs such as studies including FIH design with Caucasian and Japanese, as well as patients in one protocol, please feel free to contact us here.