CTIS soon the single entry point for submitting clinical trials in the EU


As of 31 January 2023, all new clinical trials with medicinal products in the EU and EEA countries must be submitted through the Clinical Trials Information System (CTIS). Regardless of the EU member state or EEA country in which the trial will be conducted, the only submission channel will be CTIS.

Our experts have been trained on all CTIS modules and are well prepared to help you succeed under the new Clinical Trial Regulation (CTR) and with submissions via the CTIS. Our services include:

  • Review and preparation of study documentation to meet CTR requirements, including CCI and lay-man summaries
  • Submission to CTIS: part 1 and part 2
  • Follow-up of notifications of requests for information
  • Preparation and submission of answers in required timelines
  • Notifications on study milestones, as required by CTR
    • start of inclusion
    • temporary halt of the trial
    • end of trial
  • Managing the trial in Sponsor’s workspace

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