NON-INTERVENTIONAL STUDIES (NIS), OBSERVATIONAL STUDIES
NIS will be performed for approved drugs within the standard therapy. They include the documentation of patient selection, treatment and outcome.

Usually, these studies are intended for the documentation of the use of a drug under "field conditions", i.e. without the "experimental bias" of clinical studies. As such studies are often initiated to expand the safety experience on a drug, large sample sizes will become necessary. This implies specific logistic problems for Clinical Operations which can easily be handled by Omega Mediation.

Omega Mediation has wide experience in longitudinal as well in cross-sectional studies in various indications.