Our Services

Our Services

The CTR at Keio University Hospital supports the studies that contribute to the improvement of disease prevention and their diagnosis and treatment, such as investigator-led clinical study, translational research, observational research, and disease registration.
Depending on the purpose of the research project, we provide a variety of support services from preparation of clinical research strategy to implementation. We also contact and coordinate with the Keio University School of Medicine, Keio University Hospital, and the doctors, researchers and relevant departments of any facilities necessary.

Project Management

  • Project Management of Investigator-led clinical trial / clinical research
  • Research Design Consultation
  • Support for Protocol, Informed Consent (IC), and Operating Procedure Development
  • PMDA Consultation and Response Support
  • Clinical Trial Office Support(including contracts development and fund management)
  • Communication and Coordination with Participating Facilities in Multicenter Collaborative Research
  • Research Frameworks Construction Support
  • Clinical Research Insurance Support

Clinical Study Coordination

  • Coordination with Stakeholders (Investigators, Sub-investigator, Sponsors, Hospital Staff, etc.)
  • Assistance on Development and Revision of IC
  • Assistance on Determining Subject Eligibility
  • Assistance on Explanation and Consent Acquisition to Subjects
  • Assistance on Case Registration
  • Schedule Management, Care, Examination Support at Subject Visit
  • Support for Preparation and Entering of Case Reports
  • Assistance of Development of SAE Reports
  • Support for Direct Access and Audit, etc.

Statistical Analysis

  • Investigator-led Trial / Clinical Study Biostatistics
  • Statistical Advice for the Development of Research Design and Protocol
  • Statistical Analysis of Clinical Trial Data Using SAS
  • Statistic Advice on Paper Preparation
  • Biostatistics Education for Researchers

Data Management

  • Protocol Development Support
  • Case Report Design and Review
  • EDC Setup (Construction and Validation)
  • CDMSA Setup (Construction and Validation)
  • Case Registration System Setup (Construction and Validation)
  • Case Report Data Cleaning and Query Creation


  • Monitoring Consultation
  • Monitoring Education for Researchers
  • Monitoring Plan Creation Support (Depending on quality required)
  • Central and On-site Monitoring

Other Services

  • Registration of Clinical Research Insurance
  • Procurement of Placebo Formulation
  • Outsourcing of Equipment and Documentation Necessary for Clinical Examination
  • Audit/Safety Management Consultation