Post-Approval (Phase IIIb-IV Studies Registries)

PRA's Late Phase Services 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. Our post-marketing studies help to identify trends and signals in large "real life" populations since the number & type of patients and their length of exposure to the product can vary greatly from those studied in the earlier phase clinical trials.

Our leadership, located in Horsham, PA and Mannheim, Germany, provides a global perspective for the late phase studies. Their experience provides PRA staff with a complete operational understanding of the challenges involved in conducting global and regional post-Approval studies. Industry-leading strategic, scientific, medical and epidemiological experts support PRA's Late-Phase Operational Team.

PRA's Late Phase Service offerings include:

• Retrospective Studies
• Large Simple Trials (LST)
• Restricted Access Programs
• Post-Marketing Study Design
• Post-Marketing Research Training
• Disease/Product/Pregnancy Registries
• Safety Surveillance/Post-Authorization Safety Studies (PASS)