Late Phase (IIIb-IV) Studies & Registries

PRA International's Late Phase Services group plans and conducts a wide spectrum of post-marketing studies for pharmaceutical and biotech companies. PRA facilitates the Post-Marketing process through extensive experience across a variety of therapeutic areas and study designs, including:

PRA's Late Phase Services include:

• Scientific, streamlined protocol writing to support study endpoints
• Critical thinking to minimize risk and increase benefit
• Experienced global late-phase project management
• Global multilingual Study Coordinating Center to ease physician administrative burden
• Current understanding of evolving regional and local non-interventional requirements
• Rapid study start-up supported by innovative study materials
• Active participant follow-up to support long-term retention
• Electronic, paper, and hybrid data capture methods
• Flexible resourcing for evolving project needs
• 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

For functional support services such as Regulatory Affairs, Data Management, Analysis & Reporting, Submissions Management and Quality Assurance, PRA's Late Phase Services group utilizes the experience and expertise of PRA's Product Registration operational delivery teams.