Abstract
Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors propose that the sector can learn from other industries that have been outsourcing activities for a much longer time, such as the oil and gas industry. The Safety Case is put forward as a body of evidence that facilitates the continuous exchange of data, especially focused on risk management of the relationship between outsourcer and vendor. Finally, the authors will make an attempt to come to a global consensus in this area through the Allliance for Clinical Research Excellence and Safety (ACRES) network.
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