Considerations for Good Pharmacovigilance Outsourcing Practices

Abstract

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. [...]the continuously increasing outsourcing trend does not reflect pharmaceutical companies' satisfaction: in fact, the outsourcing of research and development activities has provided mixed results. [...]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 relationship with a contract research organisation. [...]service providers charge for their work based on how many hours are needed to perform a task regardless of whether they are spread throughout a week or a month. [...]from a pharmacovigilance perspective, the two main variables are quality and cost. [...]it is rare that good quality work is cheap. The client needs to have in mind that service providers are for-profit companies with different business models and profit-sharing arrangements, which are likely to influence performance. [...]the client will need to pay for the service provider's facilities (such as office space and information technology), their overheads (such as finance, commercial, human resources), as well as for the people who will directly perform the tasks outsourced to them. [...]the less people are paid the more likely it is that they will be inexperienced (because more experienced and skilled personnel cost more) and if the service provider has insufficient project funding, it is likely that the...