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.
Let's talk about what you're looking for.
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.
Syneos Health has one of the largest pharmacovigilance (PV) and GRM teams in the industry. Our broad experience will help ensure you are supported across all therapeutic areas and stages of development:
Currently supporting
130+
with GRM Solutions
Our GRM leadership team has worked with
90%
of all currently active REMS programs
Our GRM team includes
>150
experts
Our Global Risk Management and REMS solution
Our solution provides a new option that complements sponsors' internal GRM activities, allowing companies to focus on the science of GRM, while we provide operational excellence, scalability and optionality.
Establish successful foundations
- GRM organization design, process and controls
- Asset-specific GRM strategy
- GRM roadmap
- Industry intelligence and market research
- Stakeholder feedback
- Advisory board and committee meetings
- Regulatory authority negotiation and readiness
Obtain GRM approval
- Develop EU RMP, aRMMs, local RMP and REMS documents
- Forms and education materials design
- Website screenshots
- Translations
- Country-specific submission package
- Health authority negotiations
- Drug Master File activities
Develop, launch and run GRM programs
- Automated RM documents distribution
- Program management (including for consortia)
- Engagement center
- GRM technology
- Omnichannel stakeholder outreach
- Print fulfillment
- AE management
- Grant management
- Internal and external training
- Quality management system
- Data migration
- Change management and stakeholder onboarding
- Local safety office in 60+ countries (via 3rd party)
Evaluate and assess GRM execution
- Tracking of global commitments and variations
- Stakeholder surveys
- Post-authorization safety studies
- Monitoring and oversight
- Non-compliance
- Stakeholder audits
- Assessment reports
- Data analysis
- Patient support and hub integrations
- Health authority inspections support
Full-Service REMS powered by advanced, scalable technology and deep life sciences expertise
Whether launching a new program, transitioning an existing one or managing a shared REMS, we deliver innovative, compliant tech-enabled solutions that reduce stakeholder burden, ensure FDA compliance and deliver operations excellence throughout the REMS lifecycle. We are the only REMS service provider who can, and is, delivering every aspect of REMS program requirements in-house.
Our experience:
- Supporting GRMR programs since 2010
- Our GRMR portfolio includes ~30 programs
- Supporting 130+ customers with GRM solutions
- Our leadership team has worked on 90% of all currently active REMS programs
- Comprehensive GRMR experience across the entire spectrum of program designs in 14 therapeutic areas
- GRMR leaders and experts thoughtfully recruited, and a growing team of >150 experts
- Industry-leading REMS Engagement Center leveraging top talent to provide your stakeholders with premier service
- GRMR Technology platform based on purpose-built proprietary automated workflows to drive efficient operations
- Delivery of exceptional outcomes to GRMR sponsors, never losing an awarded program to competition
- Extensive experience preparing REMS and RMP submissions
Innovating REMS Delivery Across New, Transitioning and Shared Programs, with Scalable, AI-Enabled Technology
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