Risk Management & REMS
ParagonRx offers a continuum of services to support the strategy, design, development, documentation, approval, and implementation of risk management programs or REMS, including:
Evidence-Based Analysis
- An evidence-based analysis (RxFMEA®) of the medication delivery process to identify specific points in the care process at which interventions will be most effective and least disruptive to care
- Benefit-risk analysis to determine which risks can be addressed by labeling and which require interventions beyond labeling
- Strategy tradeoff analysis for identified stakeholders
REMS Planning & Design
- REMS strategy development considering regulatory, health care provider, and patient stakeholders
- Collaborative design with stakeholders, using ethnography and other methods, to ensure program elements are feasible and acceptable
- On-site REMS Coordination Office to support the planning and internal/external REMS coordination process
Regulatory Preparations
- REMS documentation for internal and regulatory review
- Advisory Committee preparations
- Contingency planning and preparing for FDA/EMEA negotiations
- 90-day pre-PDUFA date action planning
Implementation Readiness
- On-site REMS Coordination Office to assist in the implementation of your REMS program
- Project management services to maximize program success
Operations & Assessment
- Defining REMS assessment protocols, creating survey instruments and specifying performance thresholds
- Program operations and periodic internal/regulatory assessment/reporting
Previous page: Services Next page: Evidence-Based Analysis