Phase 1 Studies
Started as a specialized clinical pharmacology research institute in 1986, SOUSEIKAI has been in the center of Japan’s Phase 1 studies to date. Our Phase 1 studies’ rigorous scientific integrity and excellent data quality have been highly valued by domestic and foreign sponsors as well as major regulatory authorities around the world. For the last 35 years, we have conducted 1,700+ Phase 1 studies covering over 27 therapeutic areas to meet our sponsors’ various study needs.
2018-2020 SOUSEIKAI Phase1 Studies (N=153)
Many pharmaceutical and biotech companies are conducting their Phase 1 studies at SOUSEIKAI with Japanese subjects for the very first time, and these First in Japanese (FIJ) studies are now more than 1/3 of our total phase 1 studies.
FIJ studies require thorough knowledge of the traits and characteristics relating to Japanese populations, as well as quick study operations know-how so as to quickly and efficiently move towards the next phase with the existing overseas data.
At SOUSEIKAI, we always share our experience and know-how with our sponsors from as early as the timing of protocol development, helping them to obtain straightforwardly their critical FIJ data.
SOUSEIKAI Phase 1 Studies include all types of clinical pharmacology studies in Healthy Japanese, Caucasian, Chinese, Korean subjects, Patients in selected therapeutic areas, PK studies in hepatic impairment patients, and a variety of POM studies.
Food Effect studies and DDI studies can be performed in accordance with overseas regulatory guidance as well.
To discuss your potential Phase 1 project in Japan, please contact us.