CLINICAL TRIALS INFORMATION SYSTEM (CTIS)

On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.

On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.
August 3, 2021

On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional specifications, so that CTIS will be the single entry point for submitting clinical trial information in the EU.

CTIs will go live when the Clinical Trial Regulation (CTR) 536/2014/EU becomes applicable, foreseeable on January 31st, 2022, and it will repeal the existing Clinical Trial Directive 2001/20/EC and national legislation that was put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.

ASPHALION can offer you support and information to facilitate this process. The key concepts for preparation at this time include:

  • Clinical Trial Regulation 536/2014/EU basics
  • Organisation Management Service (OMS) requirements
  • Extended EudraVigilance medicinal product dictionary (XEVMPD) requirements
  • Identify “CTIS personas” within a company for training purposes
  • Identify role and permission strategies for within a company
  • Evaluate clinical trial work flow and procedures to map to new CTIS functionality and day to day use
  • Identify strategies for the transition period for existing and/or new trials
  • Identify local requirement needs in addition to centralised CTIS functions
  • Transparency requirements and strategy

 

In case you have any further questions, do not hesitate to contact us at: info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

RBDCOV | 14-months follow-up meeting

The second face-to-face RBDCOV meeting is taking place today at Palau Macaya in Barcelona! Our expert, Chris Mann, is attending the meeting in person. After

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