Flagship Biosciences is committed to the use of whole slide imaging and quantitative analysis in a regulated environment. Our work spans from GLP compliance in preclinical toxicologic pathology to 21 CFR 11 requirements for clinical trials. We also are very active in formulating strategies for meeting the needs of validation of image analysis to meet CLIA and CAP guidelines. Please contact us to see how we can run studies according to regulatory requirements, or help your organization succeed in this area.
CLINICAL TRIALS: 21 CFR 11 guidelines for pharmaceutical and device clinical trials
CLINICAL: Image analysis validation under CLIA and CAP