Department of Clinical Trial Science
Department of Clinical Trial Science consists of the Monitoring Unit, Data Management Unit, Data Science Unit, and IT Support Unit, and supports clinical development and clinical research practices for pharmaceuticals, medical devices, and regenerative medicine. As an ISO 9001 (quality management) and ISO 27001 (information security) certified organization, we ensure the quality of clinical research. We are also actively involved in education and human resource development.
While appropriately responding to the trends of the times and the demands of society, such as the digitization of clinical research and the standardization of data, we flexibly respond to the requests of researchers and continue our daily study with our experienced staff in various fields to improve the quality of clinical research data and contribute to the creation of scientific evidence.
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.