Outsourcing in the pharmaceutical manufacturing process: an examination of the CRO experience

Abstract The pharmaceutical industry is passing through a very challenging period in its evolution with the traditional approaches to drug development constantly expanding. Successful pharmaceutical organisations have recognised the need to leverage resources, and as a result, they have come to rely on the wealth of expertise provided by specialist external sources. One such source is the newly emergent sector comprising Clinical Research Organisations, otherwise known as CROs. This transition to a more integrated approach to conducting pharmaceutical Research and Development (R&D) has however led to a change in practice within the traditional working environment of the pharmaceutical sector. Although pharmaceutical manufacturers have identified a number of advantages and disadvantages as a result of working with these external agents, the potential for enhancing the partnership process still exists. Given the level of co-dependency amongst operators in the industry, it is therefore necessary that pharmaceutical firms reach a much deeper understanding of the intricacies of the buyer–supplier relationship in order to facilitate the drug development process.