CSIA Services
Clinical Trial office Support
It is the supporting service for investigational site to operate the study smoothly; especially supporting for organizing clinical trail system, and preparing and managing documentation created during the study.
- Organizing clinical trial system (GCP system)
- Organizing standard operating procedure (documentation and amendment)
- Inspection support of investigator and investigational site for site selection
- Operation support of clinical trial 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
- Training of clinical trial staff
- Other clinical trial office related support tasks
