CSIA Services
CRC Services
It is the supporting service for investigators at investigational site for smooth study operation. It is supporting tasks; nevertheless, CRCs are indispensable because they arrange / organize entire site operation for the site and sponsor for all the participants such as patients, investigators, site staff, and customer personnel.
- Subject recruitment
- Support for obtaining informed consent
- Subject management (criteria check, registration support, visit scheduling, etc.)
- Correspond with adverse event during the study
- Management support of investigational products
- Transcription support from source documents to case report form for investigators
- Preparing, archiving, and managing all the documentation such as ICF
- Supporting tasks of Investigators and site staff
- Organizing / arranging study related schedules
- Supporting the contact with sponsor
- Supporting the correspondence with monitoring and audit, etc. from sponsors and regulatory authorities
- And other clinical trial related support tasks
