Risk Benefit Optimization

Risk Benefit Optimization

Medical risk evaluation and management ensures risks are detected early and minimized, while benefits are optimized.
Risk Benefit Optimization Utilization Patterns

Accelerated approvals and regulatory pressure make it crucial to demonstrate drug safety, effectiveness, and post-approval utilization patterns, under real-world conditions

The European Medicines Agency (EMA) and Food and Drug Administration (FDA) require a Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMP) to ensure that the drug's benefits outweigh patient risks, and that risks are minimized as much as possible.

Client Results

Regulatory guidance

Get help prior to European Medicines Agency (EMA) and Food and Drug Administration (FDA) reviews, and around the communication of product safety and environmental risk issues.

Pioneering experience

We have an established record in global active safety surveillance and pharmacoepidemiology programs under the ENCePP seal.

Regulatory acceptance

Our study protocols, including EURAS/INAS, are approved and recommended by international regulatory agencies.


Over 1500 scientific and peer-reviewed articles to further understanding in health research.