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We can help you with all steps of designing and executing a post-authorisation safety study (PASS) or post-authorisation 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.
Specialised, strategic consulting
We support the development of pharmacoepidemiology plans for regulatory approval through post-marketing surveillance.
We have an established record in global active safety surveillance and pharmacoepidemiology programs under the ENCePP seal.
Our study protocols, including EURAS/INAS, are approved and recommended by international regulatory agencies.