souseikai global clinical research center

For Pharmaceutical Companies

SOUSEIKAI has been conducting clinical trials for pharmaceutical companies of all sizes around the world for the last 35 years in Japan.

With our deep understanding of clinical pharmacology and accumulated know-how, we have conducted 114 FIH studies to date, helping our sponsors safely move their IPs forward towards next steps.

2018-2020 SOUSEIKAI Phase1 Studies (N=153)

At SOUSEIKAI, our 49 in-house physicians covering over 27 therapeutic areas support the conduction of all phase studies, clinical pharmacology studies, as well as any specialized studies requiring technical excellence. With these resources and staff experience, we conduct simultaneous FIH studies, a variety of Phase 1 studies, and bridging studies of various stages for Asian and Caucasian subjects for companies interested in expanding into global pharma markets without any gap in time.

[Study Capabilities]

  • Clinical Pharmacology Studies
  • Mass Balance, Microdose Studies
  • NDA Enabling Studies
  • Studies for Promotional Purposes
  • Specialized Studies

Our five CRUs are strategically located in Fukuoka, Kumamoto, and Tokyo. Thanks to these geographic advantages, we can quickly enroll Caucasian subjects in Tokyo and Asian subjects in Fukuoka for our ethnobridging studies.

Also, the Fukuoka facilities are particularly ideal for endocrinology, dermatology, ophthalmology, orthopedics, gastroenterology, and gynecology studies among others, as they are equipped with experts in each specific area, as well as having access to specialty-related technology.

At the Kumamoto facility, urogynecology, general urology, and BE/GE studies are some of their strongest focuses, and have access to robust panels of female healthy subjects and patients.

Our Tokyo facility is favorable for companies who are based in Tokyo or have preferences for big city clinical trials. TQT studies and CNS studies are this site’s specialties among others.

At SOUSEIKAI, we are able to conduct all studies under the same facility SOPs, and as well, all SOUSEIKAI CRUs are able to use our sponsors’ SOPs. Given the increasing complexity of early phase studies, one of our strongest advantages is our flexibility to utilize and leverage the full resources of our facilities for any special study needs.

All SOUSEIKAI CRUs have extensive experience with Phase 1 studies for all therapeutic areas.

SOUSEIKAI Advantages for Pharmaceutical Companies at a glance:

  • Quick Study Setup
  • Flexibility
  • Complimentary Protocol Consulting
  • Know-how Based on 35 years of Experience
  • Proven Competitive Costs
  • Integrated Study Conduction from FIH to POC within one protocol
  • ICH/GCP compliance
  • Studies for Caucasian, Korean, Chinese, and Japanese Bridging
  • MRCT Experience
  • Well connected with Japanese Pharma and CRO industries