NEW SERVICE | CTIS TRAINING BY ASPHALION

 NEW SERVICE | CTIS TRAINING BY ASPHALION

ASPHALION has been part of the EMA CTIS stakeholder meetings and is also a CTIS Master Trainer, thus we are closely involved in the implementation of the clinical trial regulation (CTR) and CTIS.

We are pleased to introduce our new specific training services for pharma and biotech companies in order to guide them through the correct implementation of the new Clinical Trial Information System (CTIS).

Basic training –Introduction to CTIS and user management

  • Introduction to the Clinical Trial Regulation No 536/2014
  • CTIS overview
  • CTIS User access management
  • Conclusions / Recommendations

Complete training – CTIS overview and practical cases for Clinical Trial Application submission and clinical trial lifecycle management

  • Submission of an initial Clinical Trial Application in CTIS
  • Creation, submission and withdrawal of a CTA
  • Search, view and download information on clinicaltrials and clinical trial applications
  • Update of an initial CTA
  • Submission of trial results and layperson summary
  • Transparency – publication of clinical trial information
  • Work-planning and management tools

We would be glad to help you in case you have any specific doubt or need related to CTIS.

In case you have any further question or if you are interested in our training, we could organize a short call to discuss how we could help you.

You can contact us at: ctis@asphalion.com

Have a look at the detailed list of our training services HERE

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