Risk Evaluation and Mitigation Strategy
(REMS) Programs

For risk minimization that helps release your brand's maximum potential.

As patient safety continues to be a top concern for both the FDA and pharmaceutical manufacturers, many drug manufacturers are being required to develop a REMS (Risk Evaluation and Mitigation Strategy) prior to receiving regulatory approval. Yet the requirements for developing a successful REMS program are not always clear, and taking the wrong approach can delay approval or impede access to the product.

inVentiv Health is uniquely qualified to partner with pharmaceutical companies to develop REMS programs. As the only company with deep expertise in REMS consultation and a complete range of commercialization services across the product lifecycle, inVentiv can deliver a truly comprehensive REMS and risk management solution to clients on a global basis through a single point of contact.

inVentiv Health brings a balanced approach to REMS planning and design, working collaboratively with all stakeholders. Through our innovative methods, we are able to design programs that consistently protect:

• Patients from avoidable medication risks
• Brands from unnecessary restrictions to market access and commercial success
• Healthcare providers from infeasible intrusions into care delivery
• Clients from REMS-related brand failures

Working with our clients' cross-functional teams, inVentiv Health provides guidance and support through the entire REMS process, from risk assessment to program implementation. Our capabilities include:

• Risk characterization and benefit-risk profiling
• REMS program strategy development
• Quick REMS recommendations (Stage I design)
• REMS design using RxFMEA^® (Stage II design)
• REMS documentation
• Contingency planning
• FDA negotiations support
• REMS Coordination Office
• REMS assessments

REMS Providers

ParagonRx >>