Medical Center for Translational and Clinical Research
(Medical Center for Translational and Clinical Research)
The Medical Center for Translational and Clinical Research gives seamless support to the complete clinical development process, which starts with an exploration of basic ideas in the fields of medicine and bioresearch and includes the sequence from first-in-human trials to postmarketing clinical studies of pharmaceuticals, medical devices, and regenerative medicine products. As a Ministry of Education, Culture, Sports, Science and Technology center for translational research and a Ministry of Health, Labour and Welfare center for early-stage and exploratory clinical trials, the Medical Center for Translational and Clinical Research is a setting for practical implementation. Through comprehensive management of translational research projects, support for pharmaceutical affairs, and administration of cell processing facility, the Center provides the necessary support for all stages of development. At the same time, it supports the management and implementation of a wide range of clinical studies, such as phaseItrials on healthy persons and the various other clinical trials stipulated by the Pharmaceutical Affairs Law, PET microdose trials, global clinical trials conforming to ICH-GCP standards, investigator sponsored trials, clinical studies using human stem cells, gene therapy clinical studies and clinical studies under advanced medical care systems.
Clinical Development Division
To support the process of development leading to implementation, the Clinical Development Division carries out translational research into basic ideas for new medical technologies that come mainly from the academic world. Highly specialized staff, including former members of pharmaceutical companies, contract research organizations, and the Pharmaceuticals and Medical Devices Agency, give support by rapidly and reliably carrying out tasks that researchers from academic organizations generally find difficult, such as management of research and development, intellectual property strategies, procurement of funding, licensing, pharmaceutical affairs, production of regenerative medicine products, compliance with regulations, support for non-clinical testing, and support for exploratory clinical studies including preparation of documentation such as clinical study protocols and monitoring. Our six-unit cell processing facilities boast the best implementation record in the country and can provide support for diverse stem cell clinical studies. They can also be utilized as GMP-compliant facilities for clinical trials.
Clinical Trial Division
The Clinical Trial Division supports the smooth implementation of clinical research, with top priority given to protection of the subjects under study. The Division supports the application and implementation of high quality clinical trials, clinical research, epidemiological studies, stem cell research, and gene therapy research that comply with the Helsinki Declaration, good clinical practice (GCP), and guidelines on research ethics. Research at the division is managed through the use of IT. The Division has also set up the Clinical Trial Unit for carrying out early exploratory clinical trials using healthy subjects. The Division has a system for immediately responding to consultations from researchers in areas such as research design, research ethics, conformance to guidelines and investigator sponsored trials. In addition, the Division carries out proactive training for researchers in areas including GCP and research ethics.
The Administration Division is one of the branches of the Medical Center for Translational and Clinical Research, and is the division responsible for such tasks as accounting, financial affairs, personnel, general affairs and public relations for the whole Department of Medical Innovation. The Administration Division maintains a grasp of the flow of personnel, goods, money and information accompanying the activities of the Department of Medical Innovation, the Medical Center for Translational and Clinical Research, and the Data Coordinating Center, carrying out a cross-departmental role to ensure the smooth and sound management of business. The Administration Division thus supports the foundations for the Department of Medical Innovation, in order to contribute to various aspects of medicine and society, and to enable its sustainable development and financially viable operation.