Bioanalytical outsourcing strategy at Janssen Research and Development.

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.