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Full-Service Risk Evaluation & Mitigation Strategy (REMS) Solutions from Syneos One®

Providing operational excellence, scalability and optionality for brand and generic REMS sponsors

The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) so they can approve, or continue to approve, a prescription drug to ensure the benefits outweigh its risks. Although the FDA has had this authority since 2007 with the introduction of the Food and Drug Administration Amendments Act (FDAAA), it has only been used for a small number of drugs.

If there are indications that a REMS program might be required for a product then it is critical to find REMS experts who can help you prepare for, launch and maintain your REMS program.

Our interdisciplinary team is here to help and has the experts, solutions and capabilities to address whatever REMS challenge you may have.

Comprehensive, configurable REMS solutions that span the entire 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 One 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.

Our REMs Service Provider Experience

  • Supporting REMS programs since 2010
  • Full-Service REMS 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 FSR 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

Reach out to learn more about how our Syneos One team can customize an integrated REMS solution for your unique asset.

Leadership Team

Michael Carr

Michael Carr
Global Risk Management & REMS Lead

Over a decade of REMS experience, and has led the strategy, development, 
implementation and operations of over half the currently approved REMS on the market both as a manufacturer and a REMS administrator.

Carolyn Carr
Global Risk Management and REMS Engagement Center

15+ years Engagement Center & REMS experience. Responsible for delivery of all REMS engagement center services. 

Justin Wilson
Global Risk Management and REMS Technology

19+ years of Healthcare Technology experience, 10+ years REMS experience, and launched 20+ REMS applications.

Mary Orosco
Global Risk Management and REMS Account Management

8+years REMS experience, supporting >10 REMS programs for 80+ REMS Sponsors, including developing and implementing KAB surveys , assessment reports, and stakeholder audits

Paul Sheehan
MSJ, Global Risk Management
and REMS Strategy

20+ years experience designing, implementing, and delivering global risk management programs.  Participated in FDA REMS advisory panels, presented at international risk management conferences, and co-authored 16 scientific manuscripts and posters on pharmaceutical risk management activities.

Full-Service REMS is an offering of Syneos One®

Syneos One is a dedicated interdisciplinary team providing seamless delivery of asset development solutions, bringing in the right resources and expertise spanning all clinical development, medical affairs, and commercialization services needed to bring products to market, address unmet patient needs and maximize value for stakeholders.

Interested in Syneos Health?