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Our hospital opened in Shinjuku Ku, Tokyo To in 2010 as a specialized hospital to conduct clinical trials. We have carried out numerous clinical trials and clinical research in the medical field in collaboration with clients, university hospitals, regional medical institutions which support our hospital since the time of establishment.
It’s very pleasure that this time Dr. Hiroyuki Fukase, who has many achievements and excellent insight in the field of clinical trials and clinical research, has been invited to our hospital as managing director.
We will continue to enhance the quality and level of clinical trials and clinical research.
Thank you for your guidance and support.
Thank you very much for your continued support of Clinical Research Hospital Tokyo.
The ICH E6 (R2) guideline, which has been introduced into domestic regulations, requires a risk-based approach to quality control. In response to this, since taking office as the director in 2017, I have consistently worked to strengthen the quality management system. More specifically, as a systemic response established a new internal audit department, improved the data management department’s systems and enhanced SOPs in accordance with GLP. Reorganized the QMS committees such as the quality control, technical management, and education and training committees, and implemented human resource development through committee activities, and as a technical response improved the essential document filing system, and actively promote the acquisition of ISO 15189 internal auditor qualification for staff.
In the ICH E17 (General principles for planning and design of Multi-Regional Clinical Trials) guideline, which reached Step 5 in June 2018, the concept of pooled regions was introduced. In the future, it will be necessary to shift development strategies from Japanese clinical trials to Asian clinical trials. At our hospital, we are constructing a system for conducting clinical trials incorporating East Asians such as Chinese, Korean, and Taiwanese. In addition, in collaboration with CMAX Clinical Research, which is one of Australia’s biggest and the oldest dedicated clinical pharmacology sites, we are establishing a system to conduct two-site bridging studies.
The development of antibody drugs and nucleic acid medicine that specifically act on molecular targets identified by genome-wide association analysis (GWAS) is changing the flow of drug discovery. The development of new drugs that are difficult to evaluate for safety and efficacy in clinical trials by conventional evaluation methods such as gene therapy and cell therapy is also rapidly advancing. We are preparing to respond with changing clinical trial methodologies to evaluate these advanced medicines.
In order to meet your expectations, we will do our best to advance the work to fulfill the latest regulatory requirements and conduct clinical trials in response to the advancement of drug discovery technologies. We look forward to your continued support and encouragement.