The ACT EU initiative aims to identify gaps, issues and bottlenecks (regulatory, resourcing, operational) that present challenges for non-commercial sponsors in the conduct of multinational clinical trials.
The programme intends to propose pragmatic and harmonised solutions to support non-commercial sponsors setting up and conducting multi-national clinical trials across the European Union / European Economic Area.
Map of national support initiatives
The Clinical Trials Regulation aims to create a more favourable environment for the conduct of clinical research in the EU.
With input from the Clinical Trials Coordination Group (CTCG), ACT EU has identified initiatives available in each EU Member State to support non-commercial sponsors at national, EU or global level.
Related material
The ERA4Health Partnership, funded under the Horizon Europe Framework Programme, has published some relevant documents:
- Mapping of available funding sources for multinational investigator-initiated clinical trials in Europe
- Mapping of organisations supporting the planning, design and conduct of multinational investigator-initiated clinical studies at national and European level
European Commission website: Quick guide for sponsors - Clinical Trials Regulation in practice
EMA website: Getting started with CTIS - Sponsor Quickguide
EMA website: CTIS Online training module 19 for SMEs/Academia
