Site Management
- Site specific Standard Operating Procedures (SOP's)
- Site initiation and trial close-out operations
- Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
- Patient Counseling
- Patient Recruitment
- Patient Follow-up
- Trial-related documents archival and maintenance
- Reporting serious adverse events to the CRO and the IRB/IEC
- Ensuring protocol compliance
- Advising & alerting investigators of potential protocol violations
- Advising & alerting investigators of potential ICH-GCP violations
- Quality Assurance
- Audit Services
- FDA inspection preparation
