CTIS: final months to transition your clinical trials to CTIS

Is your organization ready for managing clinical trials through CTIS?

We have managed 8% of the commercial studies submitted through CTIS to date.

Sermes CRO, your trusted CTIS expert

Countdown to adapt to CTIS

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How much time is left to transition clinical trials from CTD to CTR?

There is less than a year left to transition clinical trials authorized under the old Directive (CTD) to CTIS.

Ongoing clinical trials with an end date after January 2025 must migrate to CTIS by January 31, 2025, in compliance with Regulation CTR 536/2014.

Transition process to CTIS

To transition a clinical trial, it is necessary to resubmit the study documents adapted to the new regulation. There are two options:

  1. Submit All Required Documents: Present all documents required by the Regulation, adapted to the new regulation.

  2. Submit Minimum Necessary Documents: Present the minimum necessary documents initially and then complete the submission with a substantial modification.

Authorization times in CTIS

The CTR sets a maximum of 106 days to obtain authorization. Factors such as the 15-day “winter clock stop” during the Christmas period and national holidays can influence the timelines.

CTIS timing clinical trial assesment validation Sermes CRO

Leverage Sermes CRO's expertise in CTIS!

  • We have a specialized unit in CTIS and CTR 536/2014.
  • We have handled 8% of the commercial clinical trial submissions managed by CTIS in Europe since its launch.
  • We were the first Spanish CRO to submit a clinical trial via CTIS in March 2022.
  • We have been working “within” the CTIS platform since 2017, as members of the EMA Working Group.
  • We are certified by the European Medicines Agency as “Train of Trainers” for CTIS.

Our services as CTIS experts include

  • Start-up and Maintenance of All Your Clinical Trials in Member States: Comprehensive support for starting-up and managing your clinical trials across European Union Member States.

  • Consulting in CTIS and European Clinical Trial Regulation: Expert advice and consultation on CTIS and compliance with European clinical trial regulations.

I want more information about the CTIS services provided by Sermes CRO

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