The Biomarker Research Clinical Chemistry Laboratory features newly refurbished labs equipped with state of the art instrumentation including fluorescence/luminescence/absorbance microplate reader and automated liquid handling system.
Method development and validation is conducted along the lines of current CLSI, FDA, EMEA, ISO and ICH guidance. Increasing levels of assay validation are implemented throughout the biomarker pipeline, including evaluation of:
Biomarker evaluation is conducted through a phased, protocol driven approach, in line with relevant good practice guidance (e.g.CONSORT, REMARK, STARD) using validated assays with internal quality control procedures. Sample numbers are determined through prospective power analysis by a statistician.
An appointed Quality Assurance Manager ensures all projects are conducted in line with the principles of GCLP (ICH) the QA Manager is responsible for ensuring: