REMS (Risk Evaluation and Mitigation Strategy) Technology

Since 2011 the team at Medcom Kinetics has had extensive experience writing REMS content, in both English and Spanish, developing and managing REMS portals, and providing resources for hospital pharmacy enrollees. Contact us to find out how Medcom Kinetics can support your REMS initiatives.

• Content
  • Tailored content of the ENTEREG EASE program components after acquisition of Adolor
  • Updated EASE program components for transition to Merck; update for hospital depot program
• Digital Technology
  • Developed enteregrems.com; redesigned as needed; provide access to ENTEREG EASE program components
  • Updated site for transition to Merck; updated components after revisions
  • Worked with client's PMO office to develop and launch alvimopanrems.com; update content; migrate content and materials from enteregrems.com
  • Setup submission function for hospital pharmacy enrollees

Use Case
FDA supports the use of open data standards. The use case aims to reduce the burden associated with REMS implementation and improve efficiency, improve the quality of REMS data for feedback and evaluation, and optimize safe medication use and health outcomes