OUR CAPABILITIES

Types of Sponsors, Types of Studies, Our IRB, and MORE…

 
 

By Sponsor

Pharmaceutical
Biologic
Generic
Biosimilar
Vaccine
Neutraceutical
Medical Device
Tobacco
…For Sponsors, click here

 

By Phase

First in Human (FIH)
First in Japanese (FIJ)
Phase 1 Core Studies (SAD, MAD, FE)
Phase 2/3 Studies
Post-Marketing Clinical Trials
Intervention Research
Observational Research

By Therapeutic Area

Metabolic Disease
Cardiovascular
CNS
Respiratory
Gastroenterology
Dermatology
Endocrinology
Urology / Urodynamics
Ophthalmology
Oncology
Hematology/ Hemodialysis
Gynecology

 
 

By Ethnic Population

Caucasian Studies
Chinese Studies
Korean Studies
Women’s Studies
Elderly Population Studies
Special populations
Genotyping

Specialty Studies

BAL/BMS
DPK Studies
Electroretinogram (ERG) Assay
Gastric pH Monitoring
GI Endoscopy Studies
Glucose Clamp Studies
Imaging Studies
Microdose Studies
Pain Evaluation / Cold Pressor Test
Platelet Aggregation Test
Polysomnography (PSG)
TQT Studies
Urodynamics

Front-Line / Next Generation Focus

Oligonucleotide Therapeutics
Regenerative Medicines
Medical Devices
Digital Devices

 

IRB

SOUSEIKAI's IRB is located at our own Hakata Clinic in Fukuoka, and takes place every 3rd Thursday. Sponsors can also attend the IRB via web conference services.
All studies conducted at SOUSEIKAI sites can be reviewed at our IRB.

Regarding SUBMISSION – necessary documents should be provided 10 days prior to the desired IRB Date. If submitted electronically, 7 days prior to each IRB.
After the IRB, results are usually provided by the next business day.

Details

Clinical Research

Contributing to the advancement of medical science and technology is one of SOUSEIKAI’s most important missions. We have vast experience conducting independent clinical research, resulting in the establishment of new assessment systems and improved technical procedures, now widely accepted as standard practices in Japanese clinical trials. Our deep understanding of relevant Japanese guidelines makes us a valuable team member for the 40-50 sponsor-initiated clinical research studies we conduct each year for domestic and foreign clients.
If you would like to discuss your potential clinical research project for Japan, please feel free to reach out!

Contact Us

INFRASTRUCTURE

ALL 5 of our clinical research sites, totaling 362 Beds and over 270+ Staff (30+ Physicians), work under the same SOPs, providing study size and manpower flexibility, and thus client peace of mind. And with extended network access to our parent SOUSEIKAI Medical Group’s 7 Hospitals and 4 Nursing Care Facilities, we are able to utilize these resources for any related client/study needs.

Technology / Digital Efficiency – All sites are as well equipped with Web Conference Systems, and can utilize eSource, Remote SDV, and the Digitization of Documents.

Details