Specialty laboratory assay validation confirms that a method performs reliably for its intended clinical purpose, with the depth of validation matched to how the data will be used. Exploratory biomarker assays use fit-for-purpose qualification; secondary endpoint assays require fuller validation; primary endpoint and companion diagnostic assays follow the most rigorous validation packages aligned to FDA, EMA, and ICH guidance (including ICH M10 for bioanalytical methods).
Typical validation parameters include specificity, sensitivity, accuracy, precision, linearity, range, robustness, and stability, adapted for the platform (flow cytometry, IHC, NGS, ligand binding, molecular).
For multi-site global trials, validation is followed by method transfer and inter-site qualification to ensure consistent performance across labs. Cerba Research delivers validation across CAP/CLIA and ISO 15189 accredited labs, with IVDR-compliant validation available for late-phase programs.