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Accelerating Clinical Trials in the EU

Support for non-commercial sponsors

Helpdesk for non-commercial sponsors

The helpdesk employs different measures to assist sponsors in navigating the clinical trial landscape in the European Union (EU).

Currently, the helpdesk offers tailored technical assistance on CTIS functionalities and addresses questions on regulatory requirements related to the clinical trial lifecycle. The helpdesk may also consult National Competent Authorities to provide support on specific cases. 

Submit your question now by raising a ticket in the CTIS Service Desk and indicating your status as a non-commercial sponsor in the relevant field ('User affiliation').

CTIS Service Desk

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. 

National initiatives for non-commercial sponsors

Other stakeholder initiatives*

The following initiatives by other stakeholders involved in clinical trials in the EU may also be of use for non-commercial sponsors.

Name of initiativeType of supportFocus areaDescription & Links
Enpr-EMANetworkPaediatrics

The European network of paediatric research at the European Medicines Agency (Enpr-EMA) is a network of research networks and centres with recognised expertise in performing clinical trials in the paediatric population. It is a platform for sharing good practices, and promotes research into medicines for children.

https://www.ema.europa.eu/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema

The Enpr-EMA database includes research networks and centres with recognised expertise in performing clinical studies in children.

http://enprema.ema.europa.eu/enprema/index.php 

ECRINInfrastructureManagement of clinical studies

ECRIN, the European Clinical Research Infrastructure Network,  facilitates multinational clinical research through advice and services for the set-up and management of investigator or SME led clinical studies in Europe.

Ecrin | Facilitating European Clinical Research

REDDatabaseRegulatory and ethical requirements in member states

ECRIN's Regulatory & Ethical Database, RED, helps users find relevant information to support clinical research for various study types. 

A central resource for information about clinical study regulatory and ethical requirements in Europe | ECRIN

*EMA is not responsible for the content, accuracy, or completeness of information on external websites or services linked from this site. These links are provided for convenience, and EMA does not endorse or have control over the information or services provided by third parties.

Training for sponsors

The below materials provide an overview and instructions applicable for non-commercial sponsors using the Clinical Trials Information System (CTIS):

News

  • News article

ACT EU has published two new webpages with information of interest to the network and clinical trial stakeholders.

  • 1 min read

Events