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Published online: 13 March 2017
© Springer International Publishing Switzerland 2017
Abstract Over the last approximately 20 years, the pharmaceutical industry has increasingly outsourced its research and development activities, including pharmacovigilance, with mixed results. To avoid significant failures, both clients and service providers should understand and openly discuss each other's needs, avoiding the unrealistic expectations often elicited prior to signing a contract. Clients should ensure the outsourced project is adequately resourced in terms of time allocated to it and the skills and expertise of those who will do the actual work and training. They should recognise that quality can be compromised by cheapness and that a service provider's physical distance and cultural difference are likely to interfere with communication and reciprocal understanding. Clients should always have a person in house who has a good knowledge of pharmacovigilance, so as to understand each activity in detail. This person should be involved in discussions with the service provider, assessing the support and information that the service provider requires, reviewing the vendor's work, providing continuous feedback and avoiding confrontation by focussing on the needs and challenges the service provider is facing.
1Introduction
The pharmaceutical industry has been increasingly outsourcing its activities and, in 2014, it was estimated that half of the money invested in research and development was spent on contract service providers [1]. Pharmacovigilance, a market increasing in value and projected to reach US$8 billion by 2022 [2], is no exception to this trend. Pharmaceutical companies outsource pharmacovigilance activities for various reasons, such as for cost-saving purposes, a lack of internal resources [3], increasing flexibility to cope with workload peaks or because they consider that their strengths lie in areas other than pharmacovigilance. Outsourcing is particularly attractive for pharmaceutical start-up and small pharmaceutical companies because it allows them to begin activities immediately, without the need to set up a pharmacovigilance department or invest in the significant upfront cost of a pharmacovigilance database.
However, the continuously increasing outsourcing trend does not reflect pharmaceutical companies' satisfaction: in fact, the outsourcing of research and development activities has provided mixed results. For example, a study conducted by the Avoca group [4] in 2012 showed that one in five pharmaceutical companies sponsoring a study have at one time terminated a strategic...