Non-Interventional Studies (NIS)

KOEHLER eClinical 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. 

By global NIS we work in close cooperation with Dr. Urs Gasser, ClinResearch, Switzerland.

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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