PRA understands that clinical research and safety surveillance after authorization have become increasingly important due to:
- A highly competitive global market
- Increasing regulatory demands for additional data at post-approval phase
We offer clients a range of expertise in planning studies, including:
- Setting up operational capability
- Risk management
- Use of our innovative “Tiered Approach” for designing and implementing Risk Evaluation and Mitigation Strategies (REMS) and EU-Risk Management Plan (EU-RMP) activities
The PRA “Tiered Approach” allows:
- Each REMS/EU-RMP component to be placed in one of three relevant tiers according to complexity
- Proven systems and processes to be adapted to meet each sponsor’s needs
- The flexibility to expand a program as the lifecycle of a product or study evolves
