The Regulation (EU) 536/2014 comes into force mandatorily from today for all clinical trials to be initiated!

Likewise, any clinical trial initiated before today, and not considered within the CTIS Regulation, will have to transition to CTIS before January 31st, 2025.

Likewise, any clinical trial initiated before today, and not considered within the CTIS Regulation, will have to transition to CTIS before January 31st, 2025.
January 31, 2023

This means that all Clinical Trials starting in the European Union from tomorrow onwards will have to comply with this Regulation and be conveyed through the Clinical Trial Information System (CTIS) as the common portal, aimed at homogenizing and standardizing the process across the EU.

Being ready for CTIS remains a key concern for sponsors. Asphalion, with over 20 years of experience in regulatory, scientific & safety consulting in Life Sciences has established a specific service line to help companies be ready and adapt to CTIS for their clinical trials:

 

  • CTIS portal set up and whole trial lifecycle management, including advising on the appointment of roles and permissions within the organization, the set up in the system, the request of approval from authorities across the EU and the management of notifications, modifications, and alerts.
  • Adequacy of documentation to transparency
  • Support in medical writing: IMPDs, IBs, Lay Summaries of Results, Results Reports, Annual Safety Reports, among others.
  • Training sessions customizable to client’s context to prepare clinical teams for the use of CTIS within the context of their product.

 

Likewise, any clinical trial initiated before today, and not considered within the CTIS Regulation, will have to transition to CTIS before January 31st, 2025.

Asphalion provides strategic consultancy on how most effectively carry out this transition to ensure fast adequacy of your clinical trials.

Contact us for further information: ctis@asphalion.com

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