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European Pharmaceutical Contractor
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Outsourcing of clinical activities has become a complex and expensive business with inherent risks that could, if continued in a haphazard manner, lead to the squandering of resources, both in terms of money, product registration time and personnel time. The tactical (on an individual project basis) and isolationist (limited involvement of functional groups) nature of the approaches by pharmaceutical companies toward clinical outsourcing may reduce the value that they derive from the process.
This article aims to look at the core processes involved in the selection of a CRO partner, whether a sponsor decides to approach the process in a tactical or a strategic manner. The article will describe and suggest how best to structure the sponsor's outsourcing teams to maximise the returns on investment. There should be a focus on quality in the selection process. Quality will then dictate the acceptable price. The current focus is on price, which has produced variable quality in terms of contractual delivery and regulatory acceptability.
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