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:

• Curve fitting
• Range
• Limits of Detection and Quantitation
• Accuracy
• Precision
• Sensitivity
• Specificity
• Linearity
• Interference
• Biological and technical pre-analytical factors
• Uncertainty of measurement

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.

• Human Tissue Act licensed establishment
• Sample banking freezers are located in a secure, clean, temperature-controlled environment. Freezers are alarmed, monitored frequently and their max/min temperatures logged daily.
• Aliquots of biological samples are mirror-banked.
• Paper and electronic records of sample locations are maintained. Samples are labelled using 1D and 2D bar-coding systems and the individual locations of the samples are stored electronically on the LIMS database.

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:

• Laboratory personnel are appropriately trained to perform their roles and records maintained.
• All procedures are documented as SOPs and are approved appropriately
• Routine internal audits and inspections are conducted