Dolman, Andrew, Yu, Helen and Gusev, Arkady (2020) Data driven CRO benchmarking for biomarker analysis. Bioanalysis, 12 (16). pp. 1117-1127. ISSN 1757-6180

Abstract

Outsourcing is a common strategy across the Pharmaceutical industry and clinical research. Clinical Research Organizations (CRO) 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 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 support sponsors to make better-informed decisions in vendor selection.

Item Type:	Article
Keywords:	benchmarking, bioanalysis, biomarker, CRO, outsourcing
Date Deposited:	26 Sep 2020 00:45
Last Modified:	26 Sep 2020 00:45
URI:	https://oak.novartis.com/id/eprint/42864