Post-Authorisation Safety Study

Post-authorisation safety studies (PASS) offer an important new tool to actively study safety concerns in the real world setting. A PASS is defined as any study relating to an authorised medicinal product conducted with the aim of identifying, characterizing or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. This can be an interventional (clinical trial) or an non-interventional study, imposed by an European national authority or conducted voluntarily by the MAH.

DADA can assist you with the set-up, management and design of the PASS, writing of the study protocol, progress report and final study report. At DADA we have experts in the field of clinical and pharmacovigilance services who work together to assist you in the set-up and management of your PASS.