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Regulatory Focus™ > News Articles > Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

Posted 01 October 2008 | By

From its modest start about 30 years ago as an alternative to academic institutions for laboratory and clinical work, outsourcing has grown into a $16 billion industry in the US alone. It spans all aspects of drug development, from discovery to clinical development to product approval, and even includes commercialization and postmarketing support. With more than 90% of the biopharmaceutical industry comprised of small businesses with limited resources,1 many firms outsource product development to either reduce expenses or compensate for lack of core competencies. Contract research organizations (CROs) offer an excellent outsourced resource to guide firms through the risky, costly and time-consuming myriad of drug development pathways.

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