Clinical Delivery
Clinical Operations
Study management from feasibility and site start-up through monitoring to close-out.
What's Included
- Global project management and study governance
- Global feasibility, country and site selection
- Site qualification and initiation visits
- Site start-up: contracts, budgets, regulatory packages and activation
- Monitoring: on-site, remote, centralized and risk-based (RBQM)
- Monitoring plans and source data verification/review strategies
- Site management, training and performance oversight
- Patient recruitment and retention strategies
- Trial Master File (TMF) set-up, management and QC
- Vendor selection, contracting and oversight
- IMP supply, logistics and accountability
- Study close-out and archiving