Services > Clinical Monitoring

Clinical monitoring using a risk-based approach

CRAB creates a clinical monitoring plan that can be tailored to meet your needs. CRAB provides Risk Based Monitoring and Centralized Monitoring as defined in the August 2013 guidance document issued by the FDA titled “Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring.” This is an innovative monitoring service performed by the collaboration of CRAB’s Data Management and Clinical Monitor staff and includes a risk-based assessment of the clinical trial’s complexity, endpoints and safety evaluations.

Our skilled and well trained monitors can provide the following:

Site Qualification Visits
Conducted on-site to verify the site and investigator are qualified and possess appropriate resources to conduct the clinical trial.

Site Initiation Visits
Conducted on-site or by webinar to provide your investigator and site staff the training, as outlined by the protocol, necessary to conduct the clinical trial.

Interim Monitoring Visits
Conducted on-site for source document verification confirming eligibility, consent process and accurate data submission on electronic case report forms. During the visit, monitors perform investigational product accountability, review regulatory documents and clinical trial conduct to ensure protocol adherence and subject safety.

Close-out Visits
Conducted on-site after enrollment is complete and all subjects have completed study visits. This visit includes the same elements as the Interim Monitoring Visit with additional close out responsibilities.