CLINICAL TRIALS | Transition to Clinical Trials Regulation EU 536/2014 and CTIS

January 22, 2024

Only a year left for the transition!

At Asphalion we can give you support for the clinical trials transition into the clinical trials regulation EU 536/2014 and CTIS. This online system will be implemented in the European Union, as well as in the European Economic Area for the regulatory submission, authorization and supervision of Clinical Trials (CTs).

From now on, there is going to be a single-entry point for all Clinical Trial (CT) data, and CTIS allows sponsors to apply to the 30 EU/EEA countries through a single application.

This new procedure will be mandatory for all the CTs authorized under the previous Directives and they must transition to the new CTR and CTIS before January 31st, 2025.

At Asphalion we count with a team of experts specialized in CTIS platform and CTR EU 536/2014. Their deep knowledge in European Regulation allows us to provide you with a comprehensive, multidisciplinary, and transversal support for successful management of CTs. Our experts are involved in the management and coordination of the procedure and possess technical expertise of non-clinical, clinical and CMC technical documents.

For a successful transition of a CT to CTIS, Asphalion can provide you with:

  • Transition strategy: understanding of the trial context and Client’s situation to determine complexity of the transition and requirements.
  • Assistance in prioritization of CTs for transition, according to a defined strategy, evaluating the most effective transition plan and calendar in the case of sponsors managing multiple CTs.
  • Analysis of documentation, including technical analysis, if appropriate, for their adaptation to CTR and for its homogenization in the case of multi-country CTs.
  • Management of the transition process: set up of the project, appointment of roles and permissions, preparation and Review of documentation for Parts I and II, adaptation of documents to Transparency Regulation, management of Requests for Information, and follow-up with National Competent Authorities.
  • CT lifecycle management.
  • Ad-hoc consultancy.



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