TRI’s Clinical Operations Department is responsible for clinical trial management and provides clients with highly trained study teams. These teams include a Project Manager, Clinical Research Associates (CRAs), and In-House CRAs who ensure successful site startup, maintenance, and close-out. Using a risk-based approach to site monitoring we ensure that the participant rights are protected, the data are accurate and complete, and the project is completed on time and within budget.
Key Services
- Start-Up Services
- Investigator identification and selection
- Institutional Review Board and Ethics Committee approval coordination
- Investigator contracts negotiation
- Development of Monitoring Plans and Manuals of Procedures (MOPS)
- Initial collection and review of essential documents
- Design and implementation of recruitment strategies
- Ongoing Activities
- Site payments
- Design and implementation of patient retention strategies
- Continuous training and support to address site staff turnover and deficiencies noted during monitoring
- 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
- In-House Site Management
- Remote monitoring of regulatory files
- Site queries resolution
Based on our international work, TRI’s project teams are especially knowledgeable about developing countries’ regulations and cultural differences, and have developed effective remote (also called central) monitoring procedures and tools. At any given time, TRI CRAs monitor more than 75 studies and review more than 1500 regulatory documents per month. To meet our clients’ needs, we provide our clinical operations services individually or as part of a package.
