Clinical Site Monitoring
RCRI provides comprehensive study site monitoring services. RCRI monitors support the entire study life cycle from investigator selection through database closure. Our Monitors are experts in the unique requirements associated with medical device research. This device-specific expertise is critical to ensure protocol compliance, accurate data, and regulatory compliance. For all monitored studies, RCRI prepares a sponsor approved study-specific monitoring plan. The Monitoring Plan includes detailed specifications for monitoring procedures, visit frequency, documentation requirements, training and monitor assignments.
Our Monitors are RCRI employees
RCRI does not use subcontractors to support the critical function of site monitoring. As RCRI employees, RCRI monitors work within our "Quality System"; plus, we have complete control over monitor assignments and scheduling. Additionally, all of our monitors are based out of our central office which allows our monitors to interact directly with the broader study team; such as data management, biostatistics, and regulatory services.
Clinical Site Monitoring Services
Our Monitors are experienced in a wide variety of therapeutic areas across a range of device, biologic, and IVD trials. Site assignments are made taking into consideration sponsor and study-specific requirements. Our core study site monitoring services include:
- Site Identification
- Site Qualification
- Regulatory Document Collection
- Site Initiation
- Interim Site Monitoring
- Site Management (i.e. subject recruitment strategy, query resolution, device accountability, etc.)
- Site Closure