Non-Interventional Studies (NIS)

Excelya Germany GmbH is your expert in the conducting of eCRF-based national and international non-interventional and epidemiology studies with high data quality standards. 

Non-Interventional Studies (NIS) are an essential part of the clinical development program of new pharmaceuticals, which include

Post-marketing surveillance studies (PMS)
Post authorization safety studies (PASS)
Cohort studies
Case-control studies 
Register studies 

Whereas in phase I-IV 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. 

News and Events

We proudly announce the publication "Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials" in the > Lancet 2020; 395: 1627–39

KOEHLER eClinical has been the CRO partner in this EU-funded study. For further information write to:

Major release of our
Vitessa EDC platform:

Version 8.3.0.

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