Study-Specific SOP Development
The physicians and staff of the Cardiovascular Core Labs work with sponsors to develop study-specific Standard Operating Procedures for the Core Lab image analysis. These SOPs include step-by-step procedures performed in the Core Labs, including project management, study tracking, image processing and analysis, data management and quality assurance. All aspects of image and data management are documented in the SOP and are available to the study sponsor for review. The SOP ensures documentation of all aspects of the Core Lab activities for your study and also ensures compliance with regulatory agencies.