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Non-Interventional Studies (NIS)

Non-interventional studies (NIS) are an essential part of the clinical development program of new pharmaceutics. Non-interventional trials include post-marketing surveillance studies (PMS), post authorization safety studies (PASS), cohort studies, case-control studies, and register studies. Whereas in phase 1-4 clinical trials the efficacy of an investigational product is explored in a patient population which has been selected according to strong inclusion and exclusion criteria, in non-interventional trials patients are treated under real life conditions to investigate the effectiveness of a drug.

Post-Marketing Surveillance Studies (PMS)

In post-marketing surveillance studies, the medicinal product with a market approval is prescribed in the usual manner in accordance with its approved labeling. The patient is assigned to a therapeutic strategy within current practice, not according to a protocol, and the prescription is clearly separated from the decision to include the patient in the study. Diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy. In post-marketing surveillance studies real-world data are delivered from a study population which is often excluded from clinical trials. These studies are particularly suited to gain further information regarding prognosis, life expectancy, quality of life, benefit and adverse events under real life conditions.

Post Authorization Safety Studies

Post authorization safety studies are a subgroup within post-marketing surveillance studies which investigate the frequency of already known adverse events and possible rare adverse events not yet identified. In a PASS, probable risks in special patient populations are also analyzed.

Please feel free to contact us anytime for more information on how we can support your non-interventional study.

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