souseikai global clinical research center

Frequantly Asked Questions

General

  • Q1.

    What is SOUSEIKAI?

    A1.

    SOUSEIKAI is a physician-based medical group providing a variety of high-quality medical services and clinical research dedicated to our community and the health of Japan. SOUSEIKAI specializes in three main fields: clinical research, healthcare, and nursing care.

  • Q2.

    What is the Global Clinical Research Center?

    A2.

    The Center is a part of the SOUSEIKAI Group, and consists of five clinical research units (CRUs).
    To date, together with many global pharmaceutical companies, we have conducted over 4,300 protocols
    for about 1,500 new invetigational drugs safely and efficiently.
    Our five CRUs are:

    • Hakata Clinic
    • Sumida Hospital
    • Fukuoka Mirai Hospital Clinical Research Center
    • PS Clinic
    • Nishi Kumamoto Hospital Clinical Pharmacology Center
  • Q3.

    What is the Division of International & Scientific Affairs?

    A3.

    The Division of International & Scientific Affairs aims to establish and maintain the SOUSEIKAI Global Clinical Research Center as a world leading clinical trial center, and covers scientific support, academics and training, international affairs and publicity, and business development.

  • Q4.

    What type of studies does The Center conduct?

    A4.

    Our investigators and coordinators at The Center are experienced with all phases of clinical trials from first-in-human Phase-I studies through Phase-IV post-marketing studies. Please refer to "Clinical Research" in this website for more information.

  • Q5.

    What kinds of drugs do you evaluate?

    A5.

    We have evaluated various types of drugs, such as; New Chemical Entity, New Biological Entity, New Formulation, New Indication, Generics, and Biosimilar.

Specific

  • Q1.

    What kinds of beds are available for clinical trials at The Center?

    A1.

    At The Center, we use standardized hospital beds. The number of beds described on the “SOUSEIKAI Global Clinical Research Center” webpage corresponds to the number of hospital beds currently available.

  • Q2.

    Are there synchronized timing/clock systems in each facility?

    A2.

    Each room has a radio-wave atomic clock. All of the clocks used to conduct trials are synchronized with the phone time signal each day.

  • Q3.

    Does The Center provide meals for subjects?

    A3.

    Yes. The Center dieticians are in charge of creating the subject menus based on the specifications of each protocol. Meals are catered by designated companies according to the dieticians' instructions.

  • Q4.

    When subjects are at the CRUs, is there a minimum of at least one ACLS/BLS certified individual or equivalent at the site at all times?

    A4.

    Whenever subjects are in a unit, at least one ACLS certified staff member is on site.
    All of our doctors and nurses take ACLS training. Each unit provides BLS+ACLS trainings for all staff working at the unit, and training is given by an AHA certified instructor.

  • Q5.

    How far are the CRUs from the nearest trauma or intensive care center when transferring subjects?

    A5.

    All CRUs are located within a 10-minute drive from medical centers equipped with trauma or intensive care centers. In addition, Sugioka Memorial Hospital and Nishi Kumamoto Hospital have their own medical care units

  • Q6.

    Is the emergency cart inspected regularly, and equipment tested according to CRU procedures?

    A6.

    Yes. Defibrillators / AEDs are checked daily when subjects are in the unit. For FIH studies, a backup AED is available. O2 tanks, suction equipment, medication, and IV supplies are checked every month. A designated pharmacist at each CRU is responsible for restocking used/expired medication.

  • Q7.

    Is access to the pharmacy restricted to authorized personnel?

    A7.

    Access to the investigational drug depository is restricted to investigators and pharmacists only.

  • Q8.

    Is there a central or local monitoring system installed in pharmacies/laboratories that notify staff
    if temperatures fall out of range, with evidence of action taken when issues have been detected?

    A8.

    Manual temperature monitoring is done daily for the storage rooms, refrigerators, and freezers. Automatic temperature recording for the refrigerators and freezers is done as well.
    In case of a rise in temperature, an alarm is sent to the cell phones of the pharmacists and/or lab technicians
    in charge.

  • Q9.

    What resources are utilized for recruitment of subjects?

    A9.

    Via the expertise of our subject management and recruitment team, our recruitment resources include The Center’s comprehensive network database, subject recruitment website, referrals, and word of mouth. These resources enable our team to recruit target numbers of subjects in a timely and efficient manner.

  • Q10.

    What are the differences between the methods of healthy vs. special patient population recruitment?

    A10.

    The healthy population recruitment methods are described above, in questions #9.
    Regarding special patient population recruitment, in addition to the methods of healthy population recruitment,
    we recruit by referral from doctors who are acquainted with The Center investigators.

  • Q11.

    Are there measures in place to prevent the inappropriate enrollment of a subject in multiple studies?

    A11.

    Volunteer information is registered on a network database called “JACIC Subject Registry System”, involving other trial facilities (over 30 CRUs in Japan), to prevent the inappropriate enrollment of volunteers in multiple trials. We also use our own database to avoid such enrollment issues.

  • Q12.

    Does The Center/CRU have a preferred IRB/IEC that it uses regularly? What is their affiliation (independent, regional, hospital)?

    A12.

    CRUs at The Center utilize the Hakata Clinic Institutional Review Board, and its affiliation is independent.
    For more information, Please refer to our IRB website page.

  • Q13.

    Does The Center have GCP inspections by Health Authorities? If so, what have been the results?

    A13.

    To date, we have been inspected by the PMDA (Pharmaceuticals and Medical Devices Agency, Japan) 47 times, with no violations reported. In addition, we have been inspected by the USFDA for four Phase-1 protocols, and were classified as no actions indicated (NAI).