Bioanalytical outsourcing strategy at Janssen Research and Development

Author:

Verhaeghe Tom

Abstract

The times when all bioanalytical work was supported in-house are long behind us. In the modern bioanalytical laboratory, workload is divided between in-house support and outsourcing to contract research organizations. This paper outlines the outsourcing strategy of the Janssen-regulated bioanalytical group. Keeping the knowledge of the assay and the compound internally is a cornerstone of this strategy and is a driver for balancing the workload between the internal laboratory and contract laboratories. The number of contract laboratories that are being used is limited and criteria for selecting laboratories are discussed. Special attention is paid to the experience with outsourcing clinical studies to China.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference3 articles.

1. The 20th International Reid Bioanalytical Forum

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3. OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002).www.oecd-ilibrary.org/environment/the-application-of-the-oecd-principles-of-glp-to-the-organisation-and-management-of-multi-site-studies_9789264078772-en

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