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.

1. Post-Marketing Safety Market Dynamics
Report Abstract
While it doesn’t yet resemble the landscape for Phase II/III clinical services, the outsourcing
market for Post-marketing Safety is maturing. Service providers are filling out their service
offerings and sponsors are exploring their options for strategic use of these services.
Phase IV Non-interventional Studies · Risk Management Programs · Signal Management
Activities · EU QPPV Services · Scientific Literature Searches
What service providers will learn: What sponsor’s will learn:
 Everything that you need for 2012 planning  Service provider performance and loyalty
 Growth and decline in PMSS activities evaluations for Post-marketing Safety services
conducted and outsourced  Appropriate fit for niche, mid-size, and large
 Criteria sponsors use to select providers for service providers across the 5 services
each of the 5 tested services  Proportion of products with voluntary and
 Budget allocation across the 5 services required REMS programs
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