by Ming Li, Marianne Flynn, Jay Ma, Tracey Hall, Mira Hong, Yi Su, Caitlin Boland, Mark Ma, and Ryan Pelto
Outsourcing in the drug research and development industry blossomed roughly 20 years ago in the grand scheme of globalization and specialization [1]. These days, it is rare that a drug company doesn’t employ a degree of outsourcing in some shape or form. In the bioanalytical (BA) field, it has become a rarity for a drug R&D company to conduct entire BA work in-house, i.e., from method development, qualification and/or validation to regulated sample bioanalysis to support clinical trials [2-9]. In big pharmaceutical companies, it is quite routine to outsource late-stage clinical bioanalysis. In medium sized companies, an often-adopted approach is to conduct the method development in-house and outsource the majority of sample bioanalysis, be it non-GLP, GLP or GCLP. In virtual or small companies, usually the entire BA function is outsourced.