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European Pharmaceutical Contractor

CRO Selection - A Process Revisited

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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By Sherif Odaranile, Clinical Auditor at ADAMAS Consulting

Sherif Odaranile obtained a BSc in Biomedical Sciences from Portsmouth School of Pharmacy in 1988. He qualified as an MLSO at the Queen Alexandra Hospital in Cosham before joining Eli Lilly in 1990 as a Medical Representative.

He moved on to E Merck-Lipha Pharmaceuticals initially as a Senior Medical Representative before switching to the clinical arena as a Clinical Research Associate in 1994. Sherif worked in the CNS and rheumatology areas as a Monitor and then as a Project Co-ordinator. He developed an interest in clinical contracts and outsourcing which led to roles as Contracts Manager and Business Analyst at SmithKline Beecham and Biogen Ltd between 1998 and 2001. Sherif joined ADAMAS Consulting in November 2001.


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Sherif Odaranile
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