Risk Management & REMS Strategies
Risk evaluation and mitigation strategies (REMS) are designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. The U.S. Food and Drug Administration (FDA) determines if a REMS program is necessary.
PPD has a full range of capabilities and extensive experience supporting REMS programs for clients, including:
- Commercial integration
- Communication tools and plan development
- Elements to assure safe use (ETASU) development, implementation and management
- FDA negotiation and communication
- Medical communication
- Multisponsor program development
- Observational study strategies and execution
- Pharmacovigilance activities
- Regulatory documentation development
- REMS analysis/evaluation
- Strategic planning
Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.
REMS Technology Platform Provides Complete Control
PPD’s integrated REMS technology platform simplifies the complex logistics of program management. Using Microsoft® Amalga™ and HealthVault™ technologies, sponsors can maintain control and a real-time view of all REMS components through a single dashboard. Doctors, patients and other stakeholders can access REMS programs and tools simultaneously via the platform’s customizable, user-friendly external interfaces.
PPD’s REMS technology platform is a single point for comprehensive risk management:
- Control – Allowing easy information and access management, giving you consistent control throughout the life of your product
- Seamless data management – Aggregating external participant data into a single platform, saving time and resources
- Streamlined communication – Connecting multiple sponsors, vendors and end users through user-friendly interfaces
- Stakeholder access – Providing custom interfaces to doctors, patients and others for easy access to REMS tools
- Scalability – Supporting program changes over time
Extensive REMS Experience
PPD has a broad range of experience designing, executing and managing REMS products and programs. We have designed a proven process to develop FDA-approved risk management tools, evaluation tools and methodologies, and patient and health care provider education and awareness tools. Our extensive experience in integrating REMS programs into product commercialization plans enables us to deliver solutions to our clients quickly and efficiently.
PPD understands and continually monitors regulatory, legislative and market involving product safety and benefit-risk balance. We use our comprehensive understanding of the issues to provide REMS programs that address all aspects of risk management.