Bioanalytical Outsourcing

The analysis of biological samples for drugs and their metabolites in a regulated environment is an integral part of nearly every drug development program. The toxicological and clinical programs that require bioanalytical support are critical to establishing the drug's safety and efficacy, and can involve many thousands of analyses spanning multiple species, studies and years. In a pharmaceutical R&D environment, where multiple drugs are in various stages of development, management of the logistics, costs and science involved with this process can be a complex task. Outsourcing bioanalytical work to contract research organizations (CROs) while adding another level of complexity to managing drug development, has become an essential strategy for pharmaceutical companies. Deciding when, where and what to outsource is a multifaceted exercise. An assessment of the factors affecting the decision to outsource is an important step in initiating or improving such outsourcing strategies.

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