Biomarker 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.
KCAS Regulated CTAs Services
Colorimetric analysis is a method of determining the concentration of a chemical element or ch…
Methods transferred into a new laboratory need to be re-established for regulatory compliance….
The analysis of free amino acids (20 naturally occurring) in plasma or other biological matric…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval…
Flow cytometry is a technique used to detect and measure physical and chemical characteristics…
Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytome…
Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment…
Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physi…
At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s ne…
A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed t…
KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms…
Multi-plex analysis of biomarkers is a powerful tool for screening of many analytes in a small…
Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health…
Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of…
KCAS’ Clinical Sample Kit (CSK) service provides clinical sample kits for all phases of clinic…
The Laboratory Collection Manual provides biological sample collection, processing, storage an…
Biomarkers come in many flavors and can be used as alternatives for assessing the functionalit…
Tissue bioanalysis is an essential area in understanding the extent of drug distribution, meta…