Biomarker Non-Regulated CTAs Solutions
Biomarkers are used to support drug submissions, but the term can mean a very wide range of things. Bioanalytical Biomarkers are often either for (A.) Exploratory/research purposes and non-regulated or Non-GLP – or – (B.) Secondary and Primary end points traditionally requiring regulation or GLP.
KCAS knows the questions you have about your biomarkers
At KCAS we have a number of biomarker platforms to perform single biomarker analysis or multiplexing biomarker analysis. We know the questions you should consider about matrix to use and assay sensitivity. We can help ensure that the assay is designed from the start to adequately meet the specific investigation’s ultimate goals, and KCAS will help you determine whether a qualified assay can be used to generate sufficient data on a biomarker’s potential usefulness, or if more thorough analytical validation will be required.