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International Clinical Trials

Outsourcing Evolution

Outsourcing in the pharmaceutical industry is a wellestablished practice, with a broad spectrum of outsourcing models deployed. These range from tactical staffing arrangements to complex, strategic, full-service models and from one-off contracts to preferred provider and strategic partnership agreements. Across this range of services and models, functional service provision (FSP) has emerged as a popular sourcing strategy, and enterprise-level partnership agreements between big CRO and pharma players are increasingly prevalent. Industry buyers have developed a deep understanding of different sourcing models. They are increasingly able to map the needs of their development portfolio to appropriate and varied sourcing strategies, and they select providers based on these needs. A CRO offering a full range of sourcing options is attractive as a singlesource provider to enable outsourcing managers to flex the model needed.

This article reviews some of the developments in outsourcing over time and more recent market trends. It also considers the evolution of FSP over the last 10 years and explores the benefits of enterprise-level partnerships and whether singlevendor sourcing is worth considering as a means of accessing greater efficiency and partnership with vendors.

Evolution of Outsourcing

Traditionally, two reasons existed for pharma companies to outsource to CROs: to access additional staffing or to get specific medical, scientific, or operational expertise for their trials. In the early days of outsourcing, essentially two approaches were available: a project-by-project, full-service outsourcing model − in which a pharma company delegated an entire project to a CRO to run − or contract staffing, where additional staff would be used to supplement the internal headcount as and when required.

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Colin Stanley is President at ICON Functional ServicesICONs dedicated functional outsourcing service line. Colin has over 20 years of CRO industry experience and joined ICON as a Project Manager in 2001. Since then, he has held a range of roles of increasing responsibility, enabling him to develop extensive operational, functional, and geographic expertise. Colins roles at ICON have included Chief Operating Officer of DOCS; Vice President, Clinical Operations, Asia Pacific; Director of Clinical Operations, US; and Head of EU Data Management. He also led a global, cross-divisional, process improvement initiative within ICON. Colin holds a Bachelor of Science degree in biotechnology from Dublin City University, Ireland.
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