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Medical Device Clinical Study Support Services
Construction of Clinical Study designs and implementation management
GCP regulations defines required tasks of study sponsors.
Japan MDC will provide support services to support that these tasks are carried out smoothly, based on our past achievements and experience.
If you are having problems in conducting clinical studies in Japan, please contact us!
Steps of Clinical study
Clinical study preparation
- Completion of non-clinical study
- Finalization of clinical study design and protocol
- Preparation of Study device descriptions
- Preparation of clinical study compensation insurance
- Selection of CRO
- Establishment of clinical study organization
- Investigation and selection of principal investigators and medical institutions
- Submission of clinical study plan notification
IRB approval and Agreement
- Approval by the Institutional Review Board of medical institutions
- Agreement Contract with the medical institution conducting the study
Clinical study management
- Preparation of clinical study device management procedures and instructions for handling
- Installation of clinical study devices
- Monitoring and Auditing
- Data management
- Collection of clinical study devices
- Process required to close the study
- Preparation of the final study report
GCP Reliability Investigation of Clinical Study
For medical devices manufactured overseas, we recommend the use of overseas clinical trial data whenever possible. However, the Ministry of Health, Labour and Welfare (MHLW) requires scientific and ethical compliance with Japanese GCP, as well as reliability of the study, and detailed investigations are conducted.
Japan MDC provides full support for GCP inspections in clinical research with our wealth of experience and expertise.
