Risk Evaluation and Mitigation Strategy
(REMS) Programs

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

As patient safety becomes a growing 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. Simple education materials may suffice for some products, while others may require a more complex risk management program.

inVentiv Health is uniquely qualified to partner with pharmaceutical companies to develop REMS programs. As the only company with a complete range of commercialization services across the product lifecycle, inVentiv can deliver comprehensive REMS solutions through a single point of contact. With years of experience creating solutions for products with black box warnings and risk management action plans (RiskMAPS), inVentiv has the expertise to develop REMS programs that will drive brand success and better patient outcomes.

inVentiv's Risk Evaluation and Mitigation Strategy (REMS) capabilities include:

• REMS Strategy Development
  Making the right moves early in the REMS process can determine future success, so even before a product receives a mandate from the FDA, inVentiv can provide guidance. We will analyze the risk scenario, outline the likely scope of the REMS requirements, and then develop an optimal FDA negotiation strategy.
  
  
• REMS Program Design
  Whether it is a turnkey program or a comprehensive risk management effort, inVentiv has capabilities to plan a properly scaled, well-targeted REMS program, and to coordinate it seamlessly across clinical, regulatory, and marketing.
  
  
• REMS Implementation
  After executing programs for scores of brands with safety risks, inVentiv has unparalleled expertise working in highly regulated spaces. Whatever the need – communication plans, patient registries, database development, reimbursement programs – we have the resources to deliver the solution flawlessly.
  
  
• REMS Evaluation and Reporting
  Demonstrating results is a key part of any REMS program. inVentiv's evaluation capabilities include stakeholder surveys that measure understanding of risks and processes, data management on adverse events, and design and preparation of reporting packages.

inVentiv's risk mitigation services help release the full potential of pharmaceutical brands by leveraging:

• Broad experience with REMS and other regulatory challenges
• A complete suite of REMS-related services
• A single point of service to get you to all your goals

To start achieving unmitigated success with your REMS program, contact Dan Bobear at 518-226-4116 or e-mail him at dbobear@inventivhealth.com.

REMS Providers

InVentiv Clinical Solutions >>

InVentiv Advance Insights >>

Palio >>

The Therapeutics Institute >>