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This report offers sponsors and contract research organizations (CROs) a view into the current and future market dynamics of post-marketing safety activities. Readers of the report will come away with:
(1)An understanding of the current volume of post-marketing activities, the anticipated growth and decline of Phase IV, Risk Management Programs, and Signal Management Activities (including the amount conducted and amount outsourced); (2) A look into what selection criteria sponsors use to choose service providers for particular types of post-marketing activities; (3) The types of service providers that are viewed as more desirable for particular types of post-marketing activities and (4) How a sponsor’s post-marketing budget is divided up amongst the various post-marketing activities. ISR assessed: Phase IV non-interventional studies, Risk Management Programs (REMS), Signal Management Activities, EU Qualified Person for Pharmacovigilance (QPPV), and Scientific Literature Searches. A “customer satisfaction” type ranking of service provider performance by post-marketing activity.