Risk Management

Risk evaluation and mitigation strategies (REMS) are designed and implemented during the commercialisation of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. The U.S. Food and Drug Administration (FDA) determines if a REMS program is necessary.

GCR has a full range of capabilities and extensive experience supporting REMS programs for clients, including:

  • Commercial integration
  • Communication tools and plan development
  • Elements to assure safe use (ETASU) development, implementation and management
  • FDA negotiation and communication
  • Medical communication
  • Multisponsor program development
  • Observational study strategies and execution
  • Pharmacovigilance activities
  • Regulatory documentation development
  • REMS analysis/evaluation
  • Strategic planning
risk management