Post-Authorization Safety and Efficacy Studies (PASS/PAES)
Investigating the frequency of a medicine’s known adverse events and benefits in a population of real-life users.

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Overview

We can help you with all steps of designing and executing a post-authorization safety study (PASS) or post-authorization efficacy study (PAES). Our solutions enable you to adhere to risk management requirements, establish evidence for safety & effectiveness, and assess health outcomes and economic benefits in various settings.

Key features

Specialized, strategic consulting

We support the development of pharmacoepidemiology plans for regulatory approval through post-marketing surveillance.

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.

Quality Standards

Learn more about our commitment to quality.
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Clinical Publications

Over 1,500 scientific and peer-reviewed articles to further understanding in health research.
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