Clinical trial EU submission drafted in 10 minutes

Go from protocol to fully drafted CTIS Part II documentation in minutes — save weeks of work for each EU country

  • Participant information
  • Informed consent forms
  • Recruitment arrangements
  • Site suitability
  • Investigator suitability
  • Site contracts

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CTIS documents tailored to each country

Turn one clinical trial protocol into submission-ready drafts based on local requirements, language, study design, and participant populations.

  • Country-specific formatting
  • Local-language documents
  • Expert-designed regulatory templates
  • Editable Microsoft Word downloads

From protocol to editable submission documents

  1. Select the countries included in your submission.
  2. Upload your protocol so TrialAgents can identify the required populations and documents.
  3. Review a free sample before purchasing the complete country package.
  4. Download the generated documents as editable Word files.

Country-based CTIS package pricing

Each country package includes the applicable CTIS Part II documents shown during project setup.

Personal

€150 per country

A complete CTIS Part II submission document package generated by TrialAgents.

Business

€390 per country

TrialAgents document generation adapted to your organisation's requirements and templates.

Full Service

€1,200 per country

AI document generation with regulatory expert review of the completed package.

Try TrialAgents for free

Built for sensitive clinical trial work

A pre-signed NDA is available before protocol upload. Protocol files can be deleted after generation, and completed documents remain editable by your team.

CTIS guidance and clinical trial resources

Read CTIS Guides Read clinical trial reports