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

Search News & Events

  • Filter by category

Share

Related news and events

HORIZON | siNPAIN meeting in Barcelona

The objective of this project is to create a siRNA-combined advanced therapy, which will allow a more personalised treatment for different stages of osteoarthritis. All siNPAIN partners are working hard to develop efficient therapy to improve the quality of life of those affected by osteoarthritis, a chronic joint condition that affects more and more people every year.

EVENTO | SMOT III

La semana pasada los expertos de Asphalion Marta Rayo Lunar, Izabela Bedziak y Álvaro Villarino asistieron al III congreso “Spanish Meeting on Oligonucleotide Therapeutics” (SMOT)

siNPAIN | Project poster

The siNPAIN project objective is to create a siRNA-combined advanced therapy, which will lead to more personalised treatment options for different stages of osteoarthritis.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting