TRI’s Site Monitoring Department - composed of two teams of highly qualified staff: CRAs and In-House CRAs - bring its clinical expertise to your trial using a risk-based monitoring approach. We direct your research and efficiently capture accurate data to enhance your clinical decisions, advance your patient’s safety, and ensure compliance with regulatory requirements, industry guidelines, and Standard Operating Procedures (SOPs).
Our CRAs:
- Schedule sites visits
- Verify protocol compliance
- Confirm investigator and sub-investigators’ credentials
- Monitor the investigational drug flows
- Oversee site management including ensuring the application of the site Quality Management System
- Monitor recruitment
- Verify patients’ eligibility
- Monitor critical data points
- Review Electronic Case Report Form (e-CRF) and CRF
- Control Electronic Data Capture (EDC)
- Implement solutions for each problem detected
- Coordinate Institutional Review Boards (IRBs) reports, updates and approvals
- Review Investigator’s Study File
- Prepare monitoring reports
Key Services
- Clinical Site Monitoring Services
- Site assessment and activation
- Training
- Patient recruitment and community outreach
- Monitoring of recruitment, eligibility, and informed consent procedures
- Source Data Verification
- Review of Investigational Product and accountability records
- Review of compliance with Adverse Events reporting requirements
