Post-Authorization Safety and Efficacy Studies (PASS/PAES)
Investigating the frequency of a medicine’s known adverse events, potential risks, and benefits in a population of real-life users. Robust designs and strategic implementation are key to fulfilling post-authorization commitments.
We 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, post-marketing commitments, and establish evidence for safety and effectiveness, in a real-world setting.