Clinical Trial Monitoring
Clinical monitoring services are a key part of your study success. Our monitoring approach is developed with a strong partnership between clinical operations and clinical data management.
With the success of Electronic Data Capture, the monitoring role has expanded. Our CRAs are both clinical and technical experts with EDC systems.
Our monitors are trained in site etiquette, communication, and proper documentation practices.
Clinical Monitoring Services
- Our monitoring services offer Site Qualification, Site Initiation, Site Monitoring, For Cause, and Site Closeout visits.
- PI and Site Personnel Training. Training can be conducted on-site or remotely.
- We are experts in protocol compliance, regulatory compliance and source document review.
- We offer Senior CRA services to provide oversight and guidance to field monitors (along with other in-house responsibilities).
- Creation of core documents (Clinical Monitoring Plan, eCRF guidelines, etc.)
- Performance of Sponsor-side duties like User Acceptance Testing of the EDC system from the Clinical Operations / Site perspective.
- Risk based and remote monitoring in accordance with a risk assessment plan.