Greeting
Shinobu SHIMIZU
Director,
Associate Professor
To translate the ideas and needs of clinicians into clinical practice, it is essential to ensure the quality, ethical integrity, and transparency of clinical research, while appropriately evaluating the efficacy, safety, and feasibility of pharmaceuticals, medical devices, regenerative medicine products, and medical technologies through clinical trials or specified clinical researches.
We believe that data obtained from such clinical studies will lead to regulatory approval and contribute to the development of clinical practice guidelines, thereby promoting the standardization and advancement of medical care.
At the Clinical Development Center, we focus on academia-initiated translational research, particularly by planning, designing, and managing investigator-initiated clinical trials. Through these efforts, we aim to contribute to the generation and dissemination of high-quality clinical evidence.
In addition, we support clinicians by refining research ideas derived from clinical questions encountered in daily practice, and by contributing to the development of clinical research protocols. Through these activities, we strive to facilitate the translation of research outcomes into practical clinical applications.
Overview
The Clinical Development Center supports clinical research and clinical trials conducted after the early-phase stage. Building on research projects advanced by the TR Center, it is responsible for generating evidence on efficacy and safety to enable the practical implementation of new medical technologies. The Center oversees the operational management of clinical studies and coordinates across relevant departments. In close collaboration with project managers, it promotes the strategic advancement of research and development from a comprehensive, end-to-end perspective. By working closely with other centers, it ensures that research outcomes are effectively translated into subsequent stages of development.
Division of Investigator-Initiated Trials Management
Mission: We plan, design, and manage investigator-initiated clinical trials with principal investigator, contributing to the generation of clinical evidence required for regulatory approval.
Investigator-Initiated Trials Management Office
Mission: We coordinate stakeholders involved in clinical trials, and promote the appropriate conduct of trials in compliance with GCP.
International Collaborative Clinical Research Office
Mission: In collaboration with domestic and international research institutions, we promote international collaborative clinical trials and clinical research.
Division of Specified Clinical Research Management
Mission: We facilitate the appropriate and efficient conduct of specified clinical research, advanced medical care, and the Patient-Proposed Healthcare Sercices program, contributing to the social implementation of innovative medicine and the enhancement of clinical research quality.
Advanced Medicine and Clinical Research Promotion Office
Mission: We promote advanced medical care aimed at evaluating innovative medical technologies.
Patient-Proposed Healthcare Services Promotion Office
Mission: We support the approproiate operation of the Patient-Proposed Healthcare Services program and promote improved access to advanced medical care tailored to patient needs.