In accordance with the local IRB, the CRC completes IRB study close documentation and appropriately notifies study subjects, research team, and pharmacies. The CRC works with the sponsor's clinical monitor to complete outstanding monitoring findings and queries. In addition, the CRC must comply with record retention policies of the Food and Drug Administration (FDA), the ICH, and the clinical trial agreement.
Minimize the time, cost and delays associated with on-site clinic visits by comparing data entry with source documents, on screen, continuously throughout the study.
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Catalysts’ core competency is clinical operations, building teams and augmenting staff comprised of Project Managers and Coordinators, Clinical Trial Leads, CRAs, Medical Monitors, Auditors, Site Specialists and Contract Negotiators to provide the following customizable services: