Quality Assurance Office

For reliable clinical research and development

Our goal is to protect the human rights of study subjects and to increase the reliability of clinical trials by verifying compliance with protocols, SOPs, and regulations, such as the GCP, Clinical Trials ACT, Ethical Guidelines for Medical and Health Research Involving Human Subjects, and the Declaration of Helsinki from an objective standpoint. We also support medical institutions and trial sites in system audits by evaluating design and performance of the computer system. These activities support to increase the reliability of clinical trials.