Biomarkers, Central Lab and Clinical biology services & QA
Biomarkers nowadays are largely applied to drug development in a number of distinct ways. First, they may be applied as additional diagnostic measures in a population clinically identified as having the disease. Sensitivity, specificity, and positive predictive value all must be considered for such an application.One of the most important uses of biomarkers in drug development is as an indirect measure of disease severity. A number of points should be established for such use: the marker must have a scientific rationale , it should change with disease progression in longitudinal observational studies, and must be measurable and reproducible.
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Clinical Resarch
Within the clinical research department, all efforts are invested according to the most up-to-date standardized procedures (SOP) to deliver services of feasibility of research project, protocols elaboration, submission to regulatory authorities, implementation, monitoring, validation and coordination of clinical biology services, pharmacovigilance monitoring , reporting and reconciliation of events , IMPs management , data verification and storage ; site closures and medical writing of end of study reports.
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