CSIA Services
IRB Office Support
It is the supporting service for institutional review board established by investigational site for smooth study operation; especially, preparing the documentation and operating IRB.
- Organizing clinical trial system (GCP system)
- Organizing standard operating procedure (documentation and amendment)
- Establishment support of IRB office
- Operation support of IRB office
- Organizing clinical trial contract
- Preparing, archiving, and managing all the documentation
- Supporting the contact with sponsor
- Supporting the correspondence with monitoring and audit from sponsor and regulatory authorities
- Other clinical trial office related support tasks
