TRI’s clients benefit from our full site support and monitoring services from study start-up to close-out. TRI’s in-house CRAs provide site management and logistics support to allow the field CRAs to focus on the critical aspects of the monitoring visit. Every member of TRI’s in-house clinical operations team works with clients to maximize project performance, clinical excellence, data integrity, and product safety.

Our In-House CRAs:

• Draft the study protocol and evaluate protocol compliance
• Review project materials (e.g. MOPs, SOPs)
• Correct procedures and track corrections
• Monitor regulatory documents
• Review Adverse Events (AEs) reporting
• Coordinate Institutional Review Boards (IRBs) and site communications
• Draft Case Report Forms (CRFs)
• Monitor compliance with Electronic Data Capture (EDC)
• Monitor data using Source Documentation Verification (SDV)
• Review data through our Clinical Trial Management System (CTMS)
• Prepare monitoring reports