Since its establishment as a regulatory consultancy in 1999, Cobridge has provided services related to clinical studies of medical devices originating overseas as well as in Japan.
Registrations of medical devices in Japan is increasing mainly relying upon foreign clinical data to reduce cost and time to obtain approvals. In order to use foreign clinical data for applications in Japan, foreign manufacturers must verify that the clinical study conducted in a foreign country complies with current Japanese GCPs. Conducting manual and logical data checks to verify the quality of clinical data, and preparing a clinical study report need expertise and experience.
Cobridge has supported a number of product registrations using foreign clinical data over the years since company establishment. In addition to preparing application dossiers and addressing health authority queries, Cobridge provides comprehensive consultation, such as gap analysis, whether a clinical study conducted outside Japan is usable for a Japanese product application.
Services provided by Cobridge
Leveraging foreign clinical data for Japanese registrations
- Gap analysis whether a clinical study conducted outside Japan is usable for a Japanese product application
- Verification of compliance with Japanese GCPs
- Preparation of GCP compliance check lists (required documentation for institutions, physicians, IRBs, trial agreements, investigational product, accountability, monitoring)
- Assessment of trial agreements
- Verification of data consistency between eCRF and patient listing
- Check if users on the EDC User List conducted input, modify the data to the eCRFs properly, and investigators signature on the eCRFs
- Verification between figures / tables and text in the study report
- Verification of data between result of AE judgement by the Clinical Event Committee (CEC) and AE description in the eCRF and study report (in case CEC is utilized in the study.)
- Data analysis and preparation of clinical study report
Addressing clinical-related queries from health authorities after submission
- Consultation for strategy to address queries
- Preparation of draft response to queries
- Proposal and conduct of additional statistical analysis
- Literature survey, obtaining necessary literature, and preparation of literature summary
Support for GCP “Compliance Review”
- Preparation of documents for GCP Compliance Review meetings
- Assisting with and addressing of queries from the Japanese health authority
- Attending GCP Compliance Review meetings