Bioanalytical Laboratories

PRA’s GLP-compliant laboratories are strategically located close to our Phase I Clinical Research Centers to facilitate an innovative working collaboration that enables time-critical results to be analyzed within rapid turnaround timeframes. This efficient analysis service enables clients to advance studies to the next phase much faster and clearly differentiates our bioanalytical laboratories and clinical pharmacology units as centers of excellence.

The proximity of our labs to our clinics allows us to handle the most time-critical sample analysis.

Peter Ketelaar – Vice President, Bioanalytical Laboratory Services

Designed for Complexity

PRA’s bioanalytical laboratories are managed, staffed, and supported by industry leading experts who have the scientific knowledge and experience to successfully deliver the most complex of studies.

Proactive with our science and always looking to the future, our technology investments and innovative service offerings such as large molecule protein analysis with LCMS has earned our laboratories widespread regard for high scientific standards.

With global facilities allowing for the transfer of assay methods (small and large molecules) from between our labs, we enable our clients to think global while acting local.

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Bioanalytical Laboratories

PRA operates GLP-compliant and harmonized bioanalytical laboratories in the United States (Lenexa, Kansas) and Europe (Assen, The Netherlands). Both laboratories are co-located with PRA’s Phase I clinics to enable close collaboration and rapid turn-around for time-critical studies which enables faster drug development decision making - a critical requirement for today’s adaptive trials. PRA offers large and small molecule pharmacokinetic (PK) and pharmacodynamic (PD) sample analysis in both the US and the Netherlands. Our small molecule services include LC/MS/MS and HPLC analysis. Our large molecule services include PK, PD and immunogenicity testing (ADA) via ELISA, MSD, Imperacer and LC/MS/MS to support the entire range of studies in a development program. We support studies from late discovery through all phases of pre-clinical; continuing through all phases of human clinical trials. Additional services are offered in PRA’s Netherlands laboratories. One of these is Flow Cytometry to support early efficacy determinations in early Phase I studies continuing through Proof of Concept and multi-site clinical trials. Our fully equipped Clinical Chemistry Laboratory offers safety and efficacy analysis for studies run in PRA Phase I clinics as well as supporting biomarker sample analysis from a many clinical research sites. We operate quality control laboratory to support our GMP pharmacy with release testing of drug product within 24 hours. We are also equipped for C-14 and other isotopic radioactivity counting for mass balance studies. Scientifically driven, compliant with the latest regulatory guidelines and client-oriented, PRA laboratories have 30+ years of experience in providing bioanalytical services in support of clinical and pre-clinical trials for a very broad range of molecular compounds. Solutions_Bioanalytical_Lab_PK_PD_Services_Graphic Solutions_Bioanalytical_Services_Summary_Graphic