Data Driven CRO Benchmarking for Biomarker Analysis

Abstract

Outsourcing is a common strategy across the pharmaceutical industry and clinical research. CROs offer many choices for selecting outsourcing partners for bioanalytical and biomarker support. We aimed this paper to provide critical insights into CRO benchmarking and selection using a bioanalytical challenge approach performing fit-for-purpose ligand-binding assay. Bioanalytical challenge (method validation and sample analysis) offer Pharma sponsors a great opportunity to stress test CRO technical and scientific competency, quality systems and operational capabilities. In addition, CROs demonstrated their real-life performance in communication, time management and cost – key contributors to a successful sponsor-CRO partnership. Benchmarking CROs based on objective assay data and real-life experiences will help sponsors to make better-informed decisions in vendor selection.

Keywords:

• benchmarking
• bioanalysis
• biomarker
• CRO
• outsourcing

Acknowledgments

The authors would like to thank S Richards, S Cheviet and G Imbert (all Novartis) for fruitful discussions on CRO selection.

Financial & competing interests disclosure

The authors are employed in Novartis Institutes for BioMedical Research but beyond outsourcing of biomarker work to CROs, the authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2144/000112170