In a safety trial after marketing-authorization (PASS), the safety risk of a medicinal product which is a already authorized shall be determined, described or quantified, the already developed safety profile shall be confirmed or the effectiveness of risk management measures shall be measured. PASS can be either performed by one´s choice or imposed by the competent authority. This type of study cannot only be carried out as a non-interventional study, but also as a clinical trial. The term safety study means, that in the context of this study explicitly security concerns are addressed. PASS always have a test or observation plan and a study protocol for data collection.
As part of a non-interventional study, PASS are suitable for determining the frequency of already known adverse reactions under practical conditions or to identify the yet unknown, rare safety issues that previously could not be detected.
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