Li, Wenkui, Glick, Jim, Hatsis, Panagiotis, Fu, Yunlin, Chin, Harvey, Moench, Paul and Flarakos, Jimmy (2021) An integrated outsourcing practice of nonclinical LC-MS bioanalysis and toxicokinetics at Novartis small molecule drug development. Bioanalysis, 13 (12). pp. 1001-1010. ISSN 17576199

Abstract

With decommissioning of internal regulated bioanalytical (BA) and toxicokinetic (TK) capabilities, Novartis has relied on external service providers (ESPs) for all nonclinical LC-MS BA and majority of the associated TK work since 2017. This paper outlines an integrated outsourcing practice of the Novartis nonclinical LC-MS BA/TK group, which covers the roles and responsibilities of Novartis nonclinical LC-MS BA/TK expert scientific monitors, selection of ESPs for Novartis nonclinical LC-MS BA/TK studies, qualification of BA/TK ESPs, study conduct and completion, ESP oversight and evaluation, issue mitigation, and future perspectives.

Item Type:	Article
Keywords:	collaboration contract research organization CRO ESM ESP expert scientific monitor external service provider key performance indicators KSIs LC-MS bioanalysis nonclinical outsourcing study monitoring toxicokinetics
Date Deposited:	10 Jul 2021 00:45
Last Modified:	10 Jul 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44648