Bioanalytical and biomarker services

Extensive access to validated bioanalytical methods

Bioanalysis is the discipline that allows the quantitative determination of chemical entities and biomarkers in biological matrices. PAREXEL Early Phase offers the highest quality Bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices. With our advanced technology backed by 30 years of Bioanalytical experience, we have developed an extensive database with more than 500 internally developed and validated analytical methods that adhere to both ICH and FDA guidelines. Our methods have been used in more than 3,000 pre-clinical and clinical trials. New analytical methods are developed continuously for our clients. The laboratory routine performs safety testing for clinical chemistry and hematology analysis.

Laboratory accreditation

Our laboratory situated in Bloemfontein, South Africa is GLP and ISO 17025 accredited. The laboratory offers state-of-the-art chromatographic systems, including 25 LC-MS/MS instruments for use during PK sample analysis and well-equipped immunochemistry facilities for biomarker analysis. The laboratory has been audited by the FDA and WHO among other audits.

Biomarker analysis and selection: Understanding biological activity and safety profile

Cellular and soluble biomarker analyses are becoming increasingly important in clinical trials to understand the biological activity and safety profile of candidate therapies. Together with a partner laboratory, PAREXEL offers a broad scope of cellular and soluble biomarker analysis.

PAREXEL Early Phase have significant expertise to help you select relevant biomarkers for your development program, along with helping your team interpret the results and determine the implications for your therapy.