REMS; Phase IV, Non-interventional; Signal Management; EU QPPV; Scientific Lit Searches

Q3, 2011

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.

What Readers Will Learn

This report offers sponsors and contract research organizations (CROs) a view into the current and future market dynamics of post-marketing safety activities.

After reading this report, readers will come away with:

• 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)
• A look into what selection criteria sponsors use to choose service providers for particular types of post-marketing activities
• The types of service providers that are more desirable for particular types of post-marketing activities
• 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
• Signal Management Activities
• EU Qualified Person for Pharmacovigilance (EU QPPV)
• Scientific Literature Searches
• A "customer satisfaction" type ranking of service provider performance by post-marketing activity