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.
This report explores the clinical outsourcing market of Post-marketing clinical studies, discusses sponsors use of service providers, as well as drivers for specific service provider selection.
- 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 the following activities: Phase IV non-interventional studies, Risk Management Programs, Signal Management Activities, EU Qualified Person for Pharmacovigilance (EU QPPV), and Scientific Literature Searches
- A “customer satisfaction” type ranking of service provider performance by post-marketing activity
- Market Dynamics: This report leads off with a discussion about sponsors’ present-day attitudes toward the outsourcing of post-marketing safety activities and how those attitudes change, depending on the service. This section then goes on to outline sponsors’ predicted growth and decline in the conduct of post-marketing safety activities and the outsourcing of these.
- Service Providers: This section first profiles the leadership perceptions and usage of a host of different large and mid-size CROs and specialty safety providers. It then goes on to discuss the performance strengths and weaknesses of several specific service providers and compares performance across service provider size segments.
- Provider Selection Drivers: Here, ISR provides a service-by-service look at the criteria that sponsors use to select their service providers. Additionally, we also discuss the primary drivers of service provider NON-awards.
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