Risk Management & REMS Strategies
Expert risk management support to navigate your product’s success
Bringing a new pharmaceutical product to market is a major milestone, and the safety of patients is at the heart of the process. If your drug presents safety risks that cannot be managed through labeling alone, the U.S. Food and Drug Administration (FDA) may require a risk evaluation and mitigation strategy (REMS) program.
Because REMS are only mandated for a small percentage of drugs, many pharmaceutical teams have limited experience with them — leading to uncertainty around what the FDA expects, what’s required, and how to navigate the process effectively. One of the biggest challenges for sponsors new to REMS is interpreting and responding to the FDA’s expectations. With deep REMS expertise and direct experience engaging with FDA, we help you anticipate, understand and meet regulatory requirements with confidence.
Comprehensive and tailored REMS
Full-service REMS program
Our risk management team works together in combining expertise in epidemiology, medical writing, registries, regulatory affairs, pharmacovigilance, project management office and contact center operations to provide comprehensive support. With our depth of knowledge and experience, we ensure every aspect of your REMS requirements are met with precision and care. By leveraging REMS data, we proactively manage risks, track progress and drive continuous improvement throughout the life cycle of the program. As a trusted leader in both the life sciences and clinical research fields, we uphold the highest standards for our REMS offerings. By managing every element in-house, we maintain full control over quality and efficiency, enabling us to deliver reliable, top-tier service tailored to your needs. Together, we’ll navigate both the initial launch and long-term regulatory challenges with ease including:
- Evaluation: Identify potential risks and assess the likelihood of a REMS requirement, ensuring proactive regulatory preparation.
- Design and document development: Develop tailored REMS strategies and materials to meet FDA standards, effectively communicating risk management plans.
- Implementation: Execute the REMS program, including provider training and certification, patient enrollment, and compliance monitoring, ensuring a smooth and compliant rollout.
- Assessment: Evaluate the effectiveness of the REMS program through ongoing assessments and knowledge, attitude, and behavior surveys, driving continuous improvement and promoting safe use behaviors.
Tailored REMS management
REMS requirements can differ significantly from one medication to another, depending on factors like the drug’s profile, intended use, patient population and the severity of potential side effects. Navigating this complexity is why we offer tailored solutions to meet the unique needs of your medication. With extensive experience in evaluating, designing and implementing REMS across more than 15 indications, we provide the guidance and regulatory insight necessary to navigate the process from start to finish. Our approach ensures a smooth, compliant journey through every stage.
Services include:
Design and Development
- Risk evaluation
- Strategic planning
- FDA negotiation and communication
- Communication tools and plan development
- Regulatory documentation development and submission to FDA
- Single- and multi-sponsor program development
- Website development
Implementation
- Website and platform implementation and hosting
- Contact Center
- Compliance monitoring
- Materials distribution
- Stakeholder, pharmacy and wholesaler/distributor audits
- Pharmacovigilance activities
- Observational study strategies and execution
- Pregnancy registry
Assessment
- REMS analysis/evaluation
- Quantitative and/or qualitative assessments of REMS effectiveness
- Knowledge, attitude, and behavior surveys
- Assessment report development
Ongoing REMS lifecycle activities
- Drug Master File
- REMS consulting
- Project management office
Innovation and technology in risk management
The PPD™ Risk Assessment & Mitigation Platform (PPD™ RAMP) is our advanced, cloud-based REMS system designed to boost efficiency, reduce costs and future-proof your REMS program management. We built and continuously improve our platform in-house, ensuring faster and more seamless implementation without relying on third-party vendors. Clients with standard REMS programs can be up and running in as fast as six months — well ahead of the typical 9-12 months in the industry.
The platform is scalable and adaptable, quickly adjusting to evolving FDA regulatory requirements. Regulatory updates can be made within days, public pages updated in a week, and process changes, like adding screens, can be implemented in just two weeks. Our platform provides easy access to up-to-date REMS information, with a single dashboard offering real-time visibility and control, making it easier and more efficient to manage complex, multi-sponsor REMS while staying compliant with the latest regulatory requirements.
PPD™ RAMP not only ensures compliance but also optimizes the REMS program for long-term success.
Experience at the core of our drug safety services
With 15 years of experience, we’ve refined a proven process that simplifies risk management, seamlessly integrating it into your commercialization plans and bringing your treatment to market faster and with confidence.
- Scientific expertise in 15+ therapeutic areas
- Supported 35+ REMS programs
- Written 100+ assessment reports, including 75+ KAB survey protocols
- Cross-functional expertise in regulatory, epidemiology, medical writing, contact centers and more
- Facilitated 3,300+ REMS pharmacy/wholesaler-distributor audits
Commitment to patient safety and compliance
We understand that patient safety and FDA compliance are critical to your product’s success — that’s why our REMS program is built on transparency, clear processes and rigorous data management to deliver reliable, seamless results.
Given the complexity of REMS programs, the first thing to consider is whether to manage your REMS in-house or outsource. If a REMS is anticipated or already mandated by the FDA, we’re here to support you from the start. Our early epidemiology and scientific affairs (ESA) consulting guide sponsors on the most appropriate risk management strategy – even before selecting a REMS provider. This upfront support sets us apart, enabling informed decisions, smoother launches and faster market entry. With in-house risk management expertise and integrated technology, we help minimize risk, maintain safe patient access and ensure regulatory alignment throughout your product’s life cycle — so you can stay focused on delivering better health care outcomes.
As a global leading service provider for pharmaceutical and biotech companies, our risk mitigation solutions and therapeutic expertise are unparalleled. We leverage our comprehensive in-house service offerings to ensure rapid implementation which accelerates market entry and simplifies complex multi-sponsor REMS.