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Services ---- REMS Programs

REMS, or Risk Evaluation and Mitigation Strategies, is a risk management plan required of pharmaceutical and biological product manufacturers by the FDA. As mandated by the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require these manufacturers to develop risk management plans that ensure the benefits of a product outweigh the risks. This plan can be as simple as generating a medication guide, or can be as complicated as providing certification training to medical professionals.

Astir Analytics has developed a series of solutions designed to help pharmaceutical and biological product manufacturers meet their REMS requirements. These solutions make use of our core strengths, and provide powerful tools to manufacturers. We enable clients to keep up with the evolving world of FDA mandated REMS requirements. In addition Astir Analytics works closely with Astir IT Solutions to develop a customer specific comprehensive set of REMS solutions

Below is a partial list of the Astir Analytics REMS solutions:

• REMS Portal
  • Reporting
  • Executive Dashboards
• Database Management
  • Web-enabled
  • Data cleaning
  • System integration with multiple data sources
  • System integration with 3rd party fulfillment vendors
• Elements to Assure Safe Use (ETASU)
  • Registration and tracking
  • Patient enrollment
  • Healthcare provider enrollment
  • Pharmacy enrollment
  • Comparative analysis
• Website and Landing Pages
  • Fast, efficient point of access
  • Information sharing platforms
  • Vehicle for effective data capture and routing
• Survey and Testing
  • Patient data collection
  • Patient awareness and knowledge testing
  • Healthcare provider attestations
  • Healthcare awareness and knowledge testing
  • Design, execution and hosting
  • Test tracking
  • Test result analytics
  • Evaluation and analytics
  • Automated recommendations
• Medication Guides
  • Tracking and monitoring interactions
  • Tracking distributions

Below is a partial list of the benefits of our REMS programs:

• Bridge the gap from design to operational execution
• Eliminates barriers for patients and healthcare providers
• Timely implementation and reporting
• Helps you meet FDA requirements

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