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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 program 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
Patient SMS Consent and Enrollment
How patients opt in to SMS communications for REMS program support
For REMS programs administered by Syneos Health, patients may choose to receive SMS communications related to program support through a paper enrollment process completed with their healthcare provider.
The enrollment form includes a separate, clearly labeled Text Message Consent (Optional) section. This consent is not pre-selected and is not required as a condition of program participation. Patients must actively indicate consent and sign the enrollment form before any SMS communications are sent.
The consent language explains that message frequency varies, message and data rates may apply, and that patients can reply STOP to opt out or HELP for assistance at any time.
After the enrollment form is received and processed, patients receive a confirmation text message asking them to reply YES to confirm their mobile number before ongoing SMS communications begin.
Our Global Risk Management and REMS solution
Our solution provides a new option that complements sponsors' internal GRM activities.
Companies can focus on the science of GRM while Syneos Health provides operational excellence, scalability and optionality.
Strategy
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
Submission
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
Implementation
Develop, launch and run GRM programs
- Automated RM documents distribution
- Program management, including 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 third party
Assessment
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, help ensure FDA compliance and deliver operational excellence throughout the REMS lifecycle.
Our experience
- Supporting GRMR programs since 2010
- Our GRMR portfolio includes approximately 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, with a growing team of more than 150 experts
- Industry-leading REMS Engagement Center leveraging top talent to provide 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
- 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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