Risk Evaluation and Mitigation Strategy (REMS)

Xcenda has been actively involved in the design and development of Risk Evaluation and Mitigation Strategy (REMS) programs since implementation of REMS by the FDA. Xcenda is pleased to announce the expansion of our REMS consulting practice, beginning with the addition of Terri Madison, PhD, MPH, as Vice President of Epidemiology and Risk Management. 

In addition to providing strategic guidance regarding REMS, we can help your team by complete the following:

• Program design
• Medication guides/patient leaflets
• Patient questionnaires
• Patient surveys (develop, deploy, analysis, and final report)
• Provider surveys (develop, deploy, analysis, and final report)
• REMS related education for healthcare providers
• Healthcare provider surveys (develop, deploy, analysis, and final report)
• Educational DVD/CDs
• Patient agreements
• Medication vial or Rx stickers
• Package warnings
• Turnkey project management

We are currently working with fellow Specialty Group companies, Lash Group and ICS, to support a variety of FDA and manufacturer mandated registry programs.  AmerisourceBergen Specialty Group's REMS related experience includes:

• Providing non-mandated registry programs since 1986
• Experience managing risk minimization programs since 1996
• 8 million+ unique patient contacts across 80 unique manufacturer programs
• 1,500+ seat call center capability including reimbursement and nursing professionals