DARWIN EU will implement the necessary paradigm shift for the delivery of reliable evidence for regulatory decision-making on the utilisation, safety and effectiveness of medicinal products throughout their lifecycle. DARWIN EU will significantly scale up in the number of studies and number of databases, while also substantially bringing down the cost of each study. This will make DARWIN EU a ground-breaking venture of Real-World Evidence generation. This ambitious endeavour cannot result from simply scaling up the traditional approaches used today. 

To implement DARWIN EU, we must remove the obstacles that currently prevent the exploitation of existing data at the required speed and quality. We need to setup procedures and tools for federated study execution to be compliant to governance rules and privacy regulations. This requires that we improve the interoperability of data, develop standardised analytics, and develop tools to host all artefacts created in studies to be re-used for future studies.

For more information on each of these topics see the menu items on the left.