Outsourcing strategy: local versus international contract research organizations

General aspects of bioanalytical (BA) outsourcing, such as: history and current outsourcing strategies; advantages, disadvantages and challenges; factors influencing contract research organization (CRO) selection; different models of contractor and CRO relationships; cost management in a CRO; and the future and perspectives of outsourcing have been discussed before [1,2]. At the 20th International Reid Bioanalytical Forum, a full session was dedicated to “collaborative partnerships between CROs and pharmaceutical companies” [3], demonstrating the increased importance of outsourcing to the pharmaceutical industry, which is experiencing probably the most turbulent time in its history due to continuous increase of drug-development costs, while blockbusters are running out of patents and fewer novel drug candidates gain regulatory approval. Neil Spooner (GlaxoSmithKline, Hertfordshire, UK) reported in his talk at the Reid Forum, that at GlaxoSmithKline, BA outsourcing had grown from approximately 30% in September 2010 to nearly 75% in March 2012, while toxicokinetics outsourcing rose from approximately 11 to 28% in the same period [3]. When talking about outsourcing in bioanalysis, one usually means regulatory bioanalysis; however, outsourcing even of discovery bioanalysis in the drug discovery stage has started. Graeme Clark (Cyprotex, Macclesfield, UK) illustrated at the Reid forum, by using real examples, the risk of wrong analytical results, since at this early stage usually no structural information on the analyte is provided to the CRO [3]. For the time being, it remains open if outsourcing of exploratory bioanalysis becomes a success story. This article presents a personal perspective on BA outsourcing strategies with a focus on differences, benefits and challenges of BA outsourcing to local (national) versus international CROs.