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European Pharmaceutical Contractor

Outsourcing Your Clinical Trial - The Search for Added Value

From a rational perspective, choosing a clinical research organisation (CRO) should be easy. They are numerous, the competition is high, and the nuts and bolts of all clinical trials are essentially the same. This has created a buyers' market with many clinical research organisations chasing the same work. It would therefore appear that choice of CRO can be determined by two tangible elements, namely price and capacity. To these should be added financial security, evidence of compliance to ICH and some indication that the study staff initiating your project will also be around to see it through to completion.

But is this process really rational? Surely the choice of a CRO should involve a balanced assessment of all potential factors, including those which may be considered 'soft' or difficult to quantify, but which may add significant value to your relationship?

This article will examine the real decisions that have to be made when choosing a contract partner. The examination will involve an honest appraisal of what an organisation should really hope to gain from such a partner in order to add real value to outsourcing activities as opposed to playing safe, basing a decision only on tangibles, and risking a poor return on investment.


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By Andy Broadhurst, Research Director at Heart Research, UK

Andy Broadhurst studied Biochemistry before joining Wyeth Laboratories as a Pharmacologist, where he completed his PhD in Central Nervous System Pharmacology. Following three years of postdoctoral research at Pierre Fabre Medicament in France, he abandoned the laboratory bench in favour of clinical research at Rhone-Poulenc. He subsequently moved to Syntex Pharmaceuticals and then on to Fujisawa GmbH in Munich as a Clinical Research Manager. Here he focused on the development of tacrolimus in kidney and heart transplantation. In October 1997 Andy joined Heart Research - a CRO specialising in cardiovascular clinical trials - as Research Director.

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