Risk Management, RMPs, and REMS

Assessment and Evaluation of REMS

REMS Assessment

The only common element of REMS is the “Timetable for Submission of Assessments”. Sponsors are required to evaluate whether the REMS for their product is meeting its goals or whether modifications to the REMS are warranted. Without clear or standardized guidance from the FDA, sponsors are challenged with how to effectively conduct, analyze, and document the results of REMS assessments. How do sponsors and the FDA measure effectiveness?

What does the ParagonRx approach to REMS assessments look like?

To assess whether patients and healthcare providers understand the risk messages contained in a REMS, ParagonRx conducts internet-hosted knowledge and understanding surveys during the required assessment intervals. Our 5-step process, which incorporates experiential learning from over 25 REMS assessment projects, includes:

ParagonRx REMS assessment methodology ensures that:

  • The assessment design satisfies FDA regulatory compliance and medical safety requirements – not traditional market research
  • Survey question design follows an FDA preferred format and is limited to the risks defined in the REMS
  • Survey questions are pre-tested with stakeholders to identify language or question structure issues assuring clarity with question intent
  • Reporting domains are structured to inform understanding of serious risks, appropriate use, or adherence to REMS requirements
  • The report of survey results can be easily incorporated into an overall REMS assessment report