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.

Want to learn more?


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.
Read more

Clinical Publications

Over 1,500 scientific and peer-reviewed articles to further understanding in health research.
Read more
Related solutions
Specialized research and consultancy to manage and prevent the known or potential risks associated with medicine.
Evaluate the probability and frequency of adverse events as part of post-marketing risk assessment for medical products.
Get help assessing the efficiency and safety of medicines to optimize drug safety.