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The EU’s New Clinical Trial System Is Just Two Weeks Away: Are You Ready?

 
• By Vibha Sharma

When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.

alarm clock
CTIS Requires Sponsors To Make Several Critical Decisions Earlier On In The Application Process • Source: Alamy

The conduct and oversight of clinical trials in the EU will undergo a radical transformation when the new Clinical Trial Information System (CTIS) goes live on 31 January 2022, paving the way for the long-awaited Clinical Trial Regulation (No 536/2014) to take effect.

CTIS has been developed by the European Medicines Agency to help deliver the many benefits that were promised in the regulation when it was adopted in April 2014, such as harmonized submission and assessment of clinical trial applications, and increased trial transparency

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