Helping you conduct post-approval studies on a global scale

Phase IV Studies

Phase IV is a generic term to qualify studies occurring after FDA or CHMP approval of a health product for marketing (in contrast to Phases I to III studies that occur during pre-approval period). Phase IV studies include several study designs depending of the scientific objective. From a randomized clinical trial (usually based on large number of patients with minimum data collection and monitoring “large simple trials”), to non-interventional/observational studies using epidemiological methods.

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