PRA provides comprehensive planning and services for all varieties of interventional and non-interventional post-marketing studies on a global scale. Our experts maintain an in-depth, current understanding of evolving regional and local non-interventional requirements necessary for successful post-marketing study success.
The Late Phase Services (LPS) team specializes in the design, planning and execution of:
- Disease, Product and Pregnancy Registries
- Including rare diseases and orphan products
- Restricted access and compassionate use programs
- Post-Marketing Study Design: PRA works with clients to identify post-approval research goals, interpret regulatory commitments, develop study designs and create a protocol synopsis to meet internal and external needs
- Post-Marketing Research Training: This training offers an overview of the global post-marketing environment, research trends, study design options, execution and operational considerations Retrospective and chart extraction studies
- Large Simple Trials (LST)
- REMS and EU-RMP
- Safety surveillance/post authorization safety studies (PASS)
- Minimal risk diagnostic and biomarker research
