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SOUSEIKAI Global Clinical Research Center

Clinical Trial Specialist

SOUSEIKAI Global Clinical Research Center

Welcome to SOUSEIKAI Global!

 

Since 1986, SOUSEIKAI Global Clinical Research Center has conducted both domestic and global trials with a track record of over 1600 studies, 4300 protocols, 400 Phase 1 Studies including 90 FIH studies, and 54 NAI GCP inspections for multiple regulatory agencies. Our pride is in providing the highest quality Phase I-IV clinical trial support to leading pharmaceutical companies and CROs worldwide, both small and large.

Our Center Stats
Studies/ Protocols:          1600+/ 4300+
Staff Numbers:                 329
Investigators:                    60
Bed capacity:                   420
Clinical Research Units:    5 (including early phase clinical trial units)
Investigator Specialties:   40+ *
Clinical Trial Experience:  Early Phase Clinical Trials, BE/BS, Patient Studies **
Quality, Safety, Efficacy:   ICH-GCP / J-GCP Compliance

 

The size of and access to our staff workforce and clinical research facilities provides the coordination, flexibility, and efficiency needed to handle studies of all sizes and complexities. Further supported by our parent company SOUSEIKAI Medical Group (2,300 employees), our network outreach spans seven general hospitals (200+ physicians), ten nursing care facilities, and extended access to related constituents and affiliates built concurrently since our founding.

Specializing in Phase I studies with healthy volunteers, FIH studies, and complex protocols with adaptive designs, it is our belief that our tried experience and resources yield benefits worth our investment. With solid follow-through from Phase I progressively on to next-step Phase II, III, and post-marketing Phase IV studies, our Center hopes to make each transition a smooth and fluid one. Integrated with a Central IRB located on-site, SOUSEIKAI Global Clinical Research Center’s drive is to expertly support both our clients and society in the pursuit and development of better, safer, and more efficient medical treatment. Please reach out to us, and allow us the opportunity to help support your clinical trial goals.

 

*Investigator Specialties
Anesthesiology, Cardiology, Cardiovascular Medicine, Clinical Pharmacology, Dermatology, Diabetes, Emergency Medicine, Endocrinology, Gastroenterology, General Surgery, Geriatrics, Geriatric Medicine, Hematology, Hepatology, Immunology, Infectious Diseases, Internal Medicine, Nephrology, Neurology, Neuropharmacology, Neurosurgery, Nuclear Medicine, Obstetrics/Gynecology, Orthopedic Surgery, Pediatrics, Plastic Surgery, Radiology, Respiratory Medicine, Pulmonology, Rheumatology, Urology


**Clinical Trial Experience and Study Specialties
Alcohol Interaction, Antidiabetic, Auto Glucose Clamp, Bacterial Culture Studies, BE/BA, Biologics, Biomarker Development, Biosimilar Studies (phase1 - 4), Bridging, Bronchial Micro Sampling/ Broncho Alveolar Lavage, CNS, CNS System Imaging Studies, Cold Pressure Test , Combination Protocol, QT/QTC, Pain Evaluation Studies, Patient Phase 1, PK/PD (Intensive, Patient), POC, CSF Sampling Studies, DDI, Dermatological, Dose Escalation, First in Human Studies (FIH), First in Japanese (FIJ), Flexible Dose/Adaptive Study Design, Gastric pH Monitoring, Gastroenteroscopy Studies, Hemodialysis, IMP Preparation, Mass Balance, Medical Imaging Studies, Microdose, Ophthalmological, Pain Evaluation, Phase 1 Studies, PSG, Special Populations, TQT, Transdermal Systems Studies, Urodynamics, Vaccine Studies
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research1986
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsChild 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteHospital
  • # of employees involved in research269
  • # of investigators60
  • Number of studies last year270
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL, Other
  • REGULATORY INFORMATION 
  • Type of IRB used by this siteCentral, Local
  • How often does your local IRB meet?Monthly
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract1 week

Contact

  • Nozomu Miyawaki
    Nozomu Miyawaki

    Senior Manager, Global Clinical Development
    SOUSEIKAI Global Clinical Research Center
    Fukuoka, Fukuoka