Assay Validation

Experience

Rapid assay development qualification procedures shorten your time from engagement to results. Cambridge Biomedical can develop an assay in different stages:

15 years of experience validating complex and esoteric assays.
Validated over 150 assays, and is actively running 55 in its CAP/CLIA lab.
Non GLP and GLP validation according to the FDA's guidance for industry: bioanalytical method validation.
Cambridge Biomedical's Quality Assurance Unit (QAU) assures the integrity of all assay validation projects.

Reporting

With each validation study we prepare and deliver a validation report for our customers. The validation report includes the method itself and the following parameters:

Accuracy
Inter and intra assay precision
Stability
robustness testing
Linearity
Specificity
Sensitivity
Interferences
reportable range
If appropriate clinical reference ranges

Cambridge Biomedical is CLIA certified, CAP accredited, and provides services that support best laboratory practices and GLP compliance. We help our clients navigate through quality and regulatory requirements from preclinical to IV studies.

Service Area :

CRO SERVICES
"Very good technically. People clearly knew what they were doing - knew how to handle assays, data management."

Pharmaceutical Clinical Trial Manager