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.