Outsourcing pharmacovigilance activities is a standard business practice in a continuously expanding market segment. In the past, outsourced safety services were limited due to con¬cerns about confidentiality, data security, and liability in cases of regulatory non-compliance, which are all still important considerations today. Because of the changing technology and regulatory environments, sponsors are reevaluating the advantages and disadvantages of out¬sourcing their pharmacovigilance obligations.

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