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CRAs carry out site qualification visit, site initiation visit, interim monitoring visit and site closeout visit to provide site training, site readiness for initiation, source document verification, CRF review/retrieval, data query resolution and completion of data at site before database lock.
Monitors with prior experience in specific therapeutic area are assigned to a project which helps in understanding the intricacies and complexities of the study protocol. The team ensures to provide quality data and delivers a package of smooth and successful site initiation, regular site performance check with feedback and successful close out of each study.
All trials are performed in strict adherence to the local regulatory guidelines, ICH GCP guidelines and the Standard Operating Procedures. |