An assay validation study can help you make important decisions to protect the integrity of your trial. You can choose three levels of service that we provide to optimize and validate your assay:
– Proof-of-concept (POC) to verify the feasibility of reagents.
– Quantification to test the validity of biomarkers by using
– method-to-method comparing studies.
– Full-validation to validate assay through standard tests to be applicable, and to support GCP and GLP studies. The validation includes intra- and inter- precision, tech-to-tech comparison, sample stability, sample recovery, linearity etc.
Assay validation studies are focused on assay performance. The validated assay is to ensure that the tested biomarker is linked to a clinical significance to support your Investigative New Drug Application (INDA) and New Drug Application (NDA).