- Domestic and international capabilities
- The CMIC's specialized system for safety data assures timely reports to regulating authorities within the set dates either in Japan or overseas.
- Fast and accurate work
- CMIC offers accurate and timely services, performed by staff with extensive work experience. Evaluation and analysis by panels consisting of specialists in a range of fields, some of whom are affiliated with CMIC and some of whom are independent.
A drug safety advisory committee consisting of experts at CMIC and outside physicians and specialists in various areas is formed to perform assessment and analysis.
- Preparation of Reports regarding Drug Safety Information
- Prepare the reports to the Japanese Authority(translation of CIOMS into Japanese / preparation of ICSR file)
- Prepare the English reports to the partner / Head Quarter(preparation of CIOMS with translation into English)
- Review and Assessment of Drug Safety Information
- (In the case of CMIC taking a role of ICCC. Generally clients take the responsibility for review and assessment.)
- Organize Safety Evaluation Committee
- Convene and manage Safety Evaluation Committee
- Report / Actions corresponding to the authority & clients
- Report to the Japanese Authority (ICCC)
- Report to the sponsor (ICCC)
- Maintenance Operation and of Data Base System for Drug Safety Information(Perceive AE / Clinical Works ADR)
- Creating a Database for drug safety information
- Operation and Maintenance of the Drug Safety Information system
- Consultation on Pharmacovigilance issues
- Consultation on Global Pharmacovigilance operating system
- Consultation on the Outsourcing of the Pharmacovigilance operation
