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Our Service

Important Notice
As of November 1st, 2015, The Center for Clinical Research, Keio University School of Medicine (Keio CCR) has transferred all the functions and activities to Clinical and Translational Research Center (CTRC), a program of Keio University Hospital. Keio CCR now serves as a clinical research division of KUH-CTRC.

  1. Planning, conducting and supporting investigator-initiated non-NDA (new drug application) trials and observational studies

    Investigators at Keio CCR and collaborating departments/institutions are actively conducting a wide variety of research projects aimed at establishing solid clinical evidence, including non-NDA trials and observational studies (cross-sectional studies, cohort studies, and case-control studies). Our experienced staff are able to assist with almost every phase of such research activities, as requested by the investigators.

  2. Support for translational research and investigator-initiated NDA trials

    We support research aimed at translating scientific discoveries into clinical applications (translational research) as well as projects intended to secure additional Ministry of Health, Labour and Welfare (MHLW) approval for novel applications of existing drugs (investigator-initiated NDA trials).

  3. Support of sponsored clinical trials by industry

    We support sponsors and investigators who wish to carry out both NDA and non-NDA trials at Keio University Hospital. The assistance we offer includes:

    • Liaising between medical/research experts at Keio and extramural partners, e.g. pharmaceutical companies
    • Conducting feasibility studies in preparation for large-scale trials
    • Consulting on protocol development
    • Helping with the preparation of Institutional Review Board (IRB)/Independent Ethics Committee (IEC) review applications
    • Efficient study coordination
      • Site setup
      • Study subject recruitment
      • Resource management
    • High-quality data management by experienced in-house data managers
  4. Support of sponsors' R&D activities related to medical devices, in vitro diagnostics and drugs

    We support the development of clinical applications for the fruits of both academic research and research carried out collaboratively between academia and industry.

  5. Quality assurance for clinical research

    We provide the monitoring and auditing services that form an essential part of academic research organization.

  6. Project management of clinical research

    We offer various indirect functions essential for promoting clinical research, such as the provision of a central office for multi-center trials, and management of complicated, large-scale, long-term, or global research projects.

  7. Clinical data management and disease registry

    Our industry-trained data managers work closely with investigators and sponsors to conduct quality clinical data management for trials and consistent operation of disease registry databases.

  8. Education and human resource development for clinical research

    We organize educational courses, workshops and seminars for health care professionals already involved or interested in clinical research (i.e. doctors, nurses, pharmacists, clinical research coordinators, data managers, biostatisticians, IRB/IEC members, and students).