Organization

The Clinical and Translational Research Center was established under the Director General, consisting of 11 departments in total. We support not only investigator-led and company-initiated clinical trials but also fast-track transition to clinical trials of research seeds at early basic research and non-clinical stages. We have also established a Steering Committee and R&D Management Committee, both of which allow interdepartmental collaboration for seamless R&D support.

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Division of Network Support

The Division of Network Support promotes personnel exchange with other hospitals and related medical institutions to advance translational research, clinical research, and clinical trials more effectively and efficiently. Through this close cooperation, we support the construction of an information infrastructure that can appropriately collect and share information on applicable cases and studies.

Division of Translational Research

In order to promptly and reliably translate basic research and non-clinical studies into clinical trials, the Division of Translational Research (1) supports activities related to intellectual property strategies and contracts of research collaboration, (2) advises on general nonclinical studies including PMDA compliance, and (3) provides the open research resources necessary for translating research including metabolomics analysis.

Division of Regenerative Medicine

In the Division of Regenerative Medicine Support, in order to quickly deliver regenerative medicine to patients, we support not only on-campus research but also those of other universities and medical institutions, ranging from basic to clinical trials.

Division of Clinical Research Support

The Division of Clinical Research Support provides diverse, start-to-finish support for the efficient implementation of high-quality projects at all stages, from clinical research aiming at the creation of new clinical evidence, to clinical trials aimed at obtaining regulatory approval. The division also provides strong support from experts in regulatory affairs, PM, DM, and monitoring.

Division of Biostatistics

For all of the ethical and scientific implications that surround clinical trials, the Division of Biostatistics primarily handles the science side of things. Biostaticians participate in designing investigator initiated clinical trials, provide statistical consultation and analysis for researchers, and are available for peer review. Our aim is to actively contribute to professional development through biostatistics education.

Division of Clinical Research Operation

The Division of Clinical Research Operation is responsible for First-in-Human (FIH) trials of drugs and new devices that are developed both in academia and industry, as well subsequent clinical research through phase IV in a safe, patient-centered environment that only an academic clinical research organization can provide.

Division of Clinical Biobanking

On-Demand type banking is specialized on the acquisition of high quality biospecimen from hospitals and the appropriate handling of these materials to promote clinical research. The experts such as molecular pathologist will support the protocol development accompanied with sampling the human materials including pathological specimen and blood. Adequate sample preparation will lead to success the variable types of clinical research.

Division of Clinical Research Planning

Division of Clinical Research Planning responds to various consultations related to medical and health researches involving human subjects, Clinical Trials Act-designated clinical researches, researches on regenerative medicine and doctor-initiated clinical trials. Through these activities, we minimize the burden on researchers and the secretariat of the committees that conducts ethical reviews, and promote high-quality researches.

Division of Clinical Research Education and Training

The Division of Clinical Research Education and Training offers a wide range of seminars and workshops to train researchers to acquire basic theories and essential skills for the planning, implementation, and analysis of clinical research. Our programs are dedicated to the pursuit of excellence in the fields of clinical research, and to develop a new generation of researchers with the essential skills to become independent clinical research investigators and to assume leadership positions in clinical research settings.

Division of Public Relations

The Division of Public Relations is in charge of communicating clinical research information to the greater society. It not only explains the latest clinical trials but also serves as a point of contact for inquiries and feedback. In particular, the division provides the late information in an easy-to-understand manner through our website. We do our best to provide the information that matters most, whether you're a patient, a doctor, or a researcher.

Division of CTR Administration

The Division of Clinical Research Administration is mainly responsible for contracts related to both doctor and industry-initiated clinical trials, general clerical work such as document management, and heading the Investigation Review Board (IRB). The division also works closely with other CTR divisions to provide clerical support for doctors and researchers to ensure the smooth implementation of clinical research.