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The potential utility of biomarkers in clinical studies, investigating either new treatments or new strategies of clinical management, is capitalising on recent advances in technology, from molecular sciences to powerful imaging, bearing the promise of expediting the discovery of new treatments.
In the active search for new biomarkers, many potential candidates can be considered side by side, allowing many failures but a few great winners.
Whether we leverage biomarkers from this extensive menu to streamline the time and cost of your development efforts, or collaborate to develop and validate the novel assays you need, we will help you identify a robust, right-fit biomarker solution.
A biomarker is a characteristic that can be objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention.
Now for Context of Use– The COU elements, are clearly laid out in the FDA guidance and provide an informative, structured exercise for identifying the biomarker’s utility.