- > Pre-clinical trials
- > Consultation for product development and planning
- > Monitoring
- > Data management
- > Medical writing
- > Patient access / recruitment
- > Site management / Study Coordinator
- > Pharmacovigilance
- > Audit
- > EDC solution
Knowledge and know-how developed over the course of many years
Network of specialists inside and outside the company
Provides strong planning support with development strategies to detailed operational schedule
- Knowledge and know-how accumulated over years
- Making full use of the wide range of know-how accumulated through its longstanding business, CMIC provides not only strategic planning but also details in designing operational plans.
- Network of inside and outside specialists
- CMIC has established a network among specialists in pharmaceutical affairs, medicine, pharmacy, pharmacology, toxicology and quality control to meet every need of its clients.
- Support for planning of development strategy and protocols
- Understanding the basic concept of the product to be developed, CMIC will specify the types of and timeline for clinical trials and other studies (human or animal) required for approval. Specific planning is the key to successful execution of the proposed strategy. Providing wide-ranging expertise, CMIC supports protocol creation, clinical study designing and detailed planning, including cost-effectiveness, in various disease areas.
- Support for quality control and related issues
- Another important aspect of drug development is accurate designing, testing and execution of quality control from the early stages. Excellent support is promised by not only the professionals at CMIC, who are specialized in GMP and documentation related to quality control submissions, but also by specialists in stability and product testing at the Institution of Applied Medicine of the CMIC Group. Support and services for quality control using the outside network are the greatest advantages of CMIC.
- In-Country Clinical Caretaker (ICCC)
- For overseas clients, CMIC serves as ICCC. Based on its proven successes, CMIC provides a comprehensive service for clinical development ranging from pre-study consultation, clinical study application, clinical study, bridging study design, communication with Japanese regulatory authorities and adverse event reports to document preparation for application.
