Global Risk Management and REMS
Providing benefit-risk solutions for medicinal products
Global regulatory authorities may require pharmaceutical companies to include risk management activities as part of their pharmacovigilance system to obtain, or retain, marketing authorization for their medicinal product. The risk management system plays a critical role in positively impacting the benefit-risk ratio and enabling patients to access these life-enhancing therapies.
In the United States, the FDA applies risk management controls through Risk Evaluation and Mitigation Strategy (REMS) programs. Whereas in Europe, and most other countries, the regulators require Risk Management Plans (RMP) with additional risk minimization measures (aRMMs) to apply the necessary controls.
Your expert partner for efficient, effective risk management design and implementation
Regardless of the terms used, designing and implementing REMS or aRMMs to address the benefit-risk profile is a complex topic and requires skilled experts to help ensure controls are balanced, effective and appropriate.
Syneos Health is here to help and has the experience, solutions and capabilities to address the global risk management challenges you may have.
For example:
- Do you have an asset in clinical development that may require risk management controls?
- Are you planning on including risk management activities as part of your marketing application?
- Have the regulators indicated that you may need a REMS or aRMMS to obtain marketing approval?
- Are you currently operating a REMS or aRMM program and are looking to transition away from your current vendors?
- Are you considering migrating your brand risk management system to a multi-sponsor shared program?
Our Global Risk Management Solutions team is dedicated to helping sponsors plan, implement, and assess measures to positively impact the risk-benefit balance of medicinal products.
We provide three core risk management services:
Full-Service REMS
Providing a comprehensive single vendor solution for US brand and generic manufacturers across the entire REMS lifecycle.
Our leadership team has worked on 90% of all currently approved REMS programs with experience on Communications Plan and ETASU REMS, spanning 14 therapeutic areas, and with programs ranging from a single sponsor to the largest multi-company shared REMS programs.
Syneos Health is the only REMS service provider who can, and is, delivering every aspect of REMS program requirements in-house, with REMS solutions that span the entire lifecycle including:
- REMS Strategy: Establish successful foundations via our REMS Diagnostic and REMS Strategic Roadmap
- REMS Submission: Write, design and publish REMS submission materials and support subsequent FDA inquiries
- REMS Development: Configure and prepare our REMS technology, engagement center and field teams to support a new program
- REMS Implementation: Ensure launch readiness, perform change management and executive hyper care throughout launch event
- REMS Operations: Implement, oversee and monitor the REMS program and conduct periodic formal assessment activities
Global Risk Management
Supporting global biopharma by implementing additional risk minimization measures to optimize the safe and effective use of medicinal products.
Establishing an effective RMP strategy and implementing appropriate aRMMs requires a global understanding of the pharmaceutical delivery system, deep knowledge of global regulatory requirements, and tight integration with the product’s overall pharmacovigilance system.
Syneos Health has one of the largest pharmacovigilance teams in the industry, and we deliver our Global Risk Management and aRMM solutions alongside our case processing, signal detection, safety surveillance, and safety submissions to drive a holistic comprehensive approach to post-marketing safety activities.
Program Management Office (PMO)
Providing a best-in-class framework to support multi-sponsor engagements
Our Project Management Office (PMO) team supports pharma clients through the development, implementation, and ongoing management of single and shared Risk Evaluation and Mitigation Strategies (REMS) and other post-marketing risk minimization projects (e.g., postmarketing requirements/commitments, global risk management plans).
Our dedicated and experienced team combines classical strategic consulting skills with core program management capabilities to help our customers navigate any challenges that require program/project management.
Services Include:
- Supplemental staff for clients needing associates with REMS and/or post-marketing risk minimization knowledge
- Project management support and expertise
- REMS and post-marketing risk minimization strategy and regulatory consulting
- Submission and assessment support
- Grant management system and support (e.g., continuing education, educational grants, investigator-sponsored research)
- Type V drug master file (DMF) holder and agent
- Knowledge, attitude, and behavior (KAB) surveys
- Usability testing, focus groups, and market research
- Food and Drug Administration (FDA) advisory committee meeting support
- PMO support for multi-sponsor and/or multi-stakeholder programs (e.g., shared REMS, post-marketing requirements/commitments, global risk management plans)
- Vendor procurement and management
Our experience:
- Supporting REMS programs since 2010
- Our leadership team has worked on 90% of all currently approved REMS programs
- Comprehensive REMS experience across the entire spectrum of REMS program designs in 14 therapeutic areas
- REMS leaders and experts thoughtfully recruited, and a growing Full-Service REMS team of >150 REMS experts
- Industry-leading REMS Engagement Center leveraging top talent to provide your stakeholders with premier service
- REMS Technology platform based on purpose-built proprietary automated workflows to drive efficient REMS operations
- Delivery of exceptional outcomes to REMS sponsors, never losing an awarded REMS program to competition
- Extensive experience preparing REMS and RMP submissions
Let's talk about what you're looking for.
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