Clinical trials in Japan

Support for clinical trials

Clinical trials for Medical Devices must be designed to achieve their goal as well as to prove the safety and efficacy of the product for patients. In any data submitted to the Japanese authorities, it is essential to consider the medical situation and environment in Japan. As an example, does a comparative device (or drug) have approval for the same purpose in Japan? Are there any concerns regarding differences in the physiological make-up of diverse races? Does the study comply with Japanese GCP requirements? Our experienced consultants can provide support to design clinical studies that consider these issues, prepare the necessary documents, and initiate/manage the study while maintaining closed communication with its clients and with the authority.

- Clinical study design/protocol design
- Pre-clinical trial meeting with PMDA (the Pharmaceuticals and Medical Devices Agency)
- Site evaluation
- Study initiation
- Study management and coordination
- Database management and quality control
- Interim reporting
- Final reporting

Support for GCP inspection preparation

The Japanese authority accepts clinical data conducted and collected in other countries if the study was performed in accordance with Japanese GCP requirements. Clinical data from foreign countries have been used for approval in Japan in several cases for medical devices. The keys are the rationale for the use of foreign data and Japanese GCP compliance.
Japan MDC provides consultation services to support GCP inspection in Japan.