Clinical Site Monitoring Services
Our site monitoring services are all-inclusive. From site selection to site closure and database lock to final CSR, we provide the highly proficient CRAs to ensure protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites.
Our CRA staff has mastered the art of coordination between the sites and study team. Our team is both regionally and office based to allow for maximum cost efficiency. Regionally based monitoring allows our CRAs to have intimate knowledge of the local languages, customs and regulations in multi-country programs.
Each CRA is dedicated to specific sites for the duration of the study in conjunction with support by an in-house management team to ensure consistent support to each site. Our CRA support staff centralization gives our CRAs direct access to time sensitive communications and management metrics that optimizes site management.
We prepare a study-specific monitoring plan for each project that will be presented to you for approval prior to monitoring implementation. This plan documents all of your study details and activities, inclusive of monitoring visit intervals and re-adjustments to the plan as required due to enrollment or site issues. To meet your project needs, we assign CRAs based upon therapeutic experience, geographical location of the sites and according to your study requirements.
Clinical Site Monitoring Core Services:
- Site Identification
- Site Qualification and Initiation
- Regulatory Document Preparation and Collection
- Budget and Contract Negotiation
- Investigator Meeting Planning and Presentation
- Site Recruitment Strategy
- Site Personnel Training
- Interim Site Monitoring
- Data Validation (on-site)
- Clinical Study Project and Material Accountability
- Site Termination