Operations & Assessment
REMS Program Operations
No program will work without robust implementation, least of all interventions delivered by third party vendors to clinicians and patients at the point of care or pharmacists at the point of dispensing. ParagonRx coordinates the efforts of third party vendors, ensuring their actions remain aligned with your intentions and interests. Regular meetings, program tracking, and reporting of exceptions and non-compliance by stakeholders are all important activities that ParagonRx can help manage.
REMS Assessment and Reporting
Once your REMS or similar program has been in place, regulators require you to regularly assess and report back to them on program effectiveness. These activities require months of advanced recruitment of stakeholders for surveys and/or advanced data collection, analysis and reporting well advance of reporting deadlines. Moreover, maintaining smooth operations and continuous refinement based on assessment findings benefits your product and complements your sales and marketing initiatives.
REMS Effectiveness Management
ParagonRx offers a REMS Effectiveness Management approach that goes beyond regulatory commitments to ensure successful REMS program implementation and evaluation. Because each REMS program is unique, the implementation and assessment of its effectiveness must be tailored to meet its specific goals. In addition to being a customized solution, REMS Effectiveness Management can include real-time program monitoring, application of continuous quality improvements, and augmenting the REMS with additional non-REMS communications and innovative tools/techniques. The end result will not only successfully accomplish the goals of the REMS, it will also improve appropriate product use.
Learn more about REMS Effectiveness Management
The Advantage
ParagonRx helps you track what's happening, keeps your REMS operational and current, satisfies regulatory assessment/reporting requirements and ensures that risks are minimized with appropriate use throughout your product's lifecycle.
