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Conducting Effective Post-Market Safety Studies

Conducting Effective Post-Market Safety Studies

IQVIA
Pages 11 Pages

Post‑market studies differ from pivotal trials because they gather real‑world evidence in community settings and include diverse patients. Designs span interventional trials to observational and database studies, each balancing validity, cost and generalisability. Design choice depends on the research question; sponsors should adopt patient‑centric approaches, involve patients early, reduce site burden and use direct‑to‑patient or hybrid models. Risk‑based monitoring and quality‑by‑design ensure compliance and data integrity.

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