Organization

Institute for Advancement of Clinical and Translational Science (iACT)

Institute for Advancement of Clinical and Translational Science (iACT)
Department of Medical Development
Drugs and Regenerative Medical Products Unit
We support researchers developing drugs and regenerative medical products by planning development strategy and managing patents, technology transfer, and regulatory affairs.
Medical Devices and In Vitro Diagnostics Unit
We support researchers developing medical devices and in vitro diagnostics by planning development strategy and managing patents, technology transfer, and regulatory affairs.
Department of Clinical Trial Science
Study Management Unit
We support sponsor investigators (principal investigators) in the management of clinical development teams. We also formulate trial schedules; construct trial implementation frameworks; assist with writing protocol or operating procedures; assist with preparation of documentation for submission to regulatory authorities; manage safety information; and support the operation of the coordination office and individual assessment committees, etc.
Monitoring Unit
We confirm that clinical trials are being conducted, recorded, and reported appropriately in accordance with protocols, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), Clinical Trials Act, and other applicable regulatory requirements by directly inspecting medical charts and archival documents.
Data Management Unit
We implement a quality management system to guarantee reliability of our clinical trial data. In order to accurately evaluate the study purpose, we examine data items required and data collection methods, design Case Report Forms, conduct registration of enrolled patients, check and encode collected data, and design, develop, manage, and operate the database.
Data Science Unit
We provide expertise in clinical trials including study designs and data analysis. We also engage in a wide variety of quantitative topics including bioinformatics.
IT Support Unit
We develop the information systems for iACT's works and support researchers and iACT's activities based on Information Technology.
Department of Clinical Research Support
Clinical Research Management Unit
We administer committees involved in managing the implementation of specified clinical trial operations to carry out the Core Clinical Research Hospital's mission, a position vital to the agency, while conducting research management activities as a medical institution and cooperating with relevant departments to establish systems inside educational and medical institutions.
Clinical Research Coordinator Unit
We coordinate clinical research to ensure it is conducted safely and appropriately, focusing on supporting patients who cooperate in clinical research and the doctors in charge of clinical trials.
Education and Training Unit
We plan and manage educational seminars on clinical research, develop e-learning tools, and disseminate resources both inside and outside the hospital.
Global R&D Unit
We support global seeds development. Specifically, we facilitate coordinated collaboration with overseas universities and research institutes as well as preparing and implementing joint global clinical research and clinical trials of individual seeds.
Quality Assurance Unit
Our audit unit objectively evaluates whether clinical research is being conducted appropriately based on its compliance with regulatory requirements, Standard Operating Procedure (SOP), and research protocols.