国立研究開発法人 国立成育医療研究センター National Center for Child Health and Development

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Scholar & Enterprise

Scholar & Enterprise

Department of Clinical Research Promotion

A core objective of the NCCHD is to develop new drugs and medical devices for maternal and child health. The Department of Clinical Research Promotion was established to enhance this mission by supporting and managing investigator-initiated and industry-sponsored clinical trials. The department also supports researchers in designing, planning, and managing clinical trials in collaboration with other departments and units. Furthermore, it provides consultations to industries and academic institutions for the development of pharmaceutical affairs.

Organization

The department consists of four units: the Clinical Research Coordination Unit, Clinical Research Planning Unit, Pharmaceutical Affairs Unit, and Project Management Unit.

Functions and services

1. Promotion and support of clinical trials

The department manages and supports investigator-initiated and industry-sponsored clinical trials. The Clinical Research Coordinators support clinical trials in accordance with Good Clinical Practice and other laws, regulations, and guidelines.

2. Planning and management of clinical trials

The department provides support (e.g., development strategies; designing and planning clinical trials; developing protocols, explanatory documents, and standard operating procedures; and progress management and correspondence with regulatory agencies) to researchers according to their goals and requirements.

3. Promotion of the development of pharmaceuticals and medical devices for maternal and child health

The department provides consultations for the development of pharmaceutical affairs to industries and academic institutions that are planning to develop pharmaceuticals and medical devices for pediatric and maternal health.