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Understanding Europe’s New Clinical Trial Regulations

EU Clinical Trial Regulation


백서

A Quick Guide to Understanding the new EU Clinical Trial Regulation (EU-CTR)

Understanding the European Union Clinical Trial Regulation 536/2014 (EU-CTR)

While the new EU-CTR will help to streamline clinical trials, which will benefit both patients and researchers, there are some challenges for Sponsors adjusting to this new regulation. Certara’s depth of expertise and full suite of transparency and disclosure services allow us to help clients successfully navigate this new regulatory territory.

Download this white paper and learn the goals of the new EU Clinical Trial Regulation, along with key timelines and best practices you need to know for a successful submission. 

What You’ll learn

  • An understanding of the new CTIS (Clinical Trials Information System)
  • How to comply with timelines for transitioning to CTIS
  • Guidelines for clinical trial data anonymization and redaction
  • Tips for increasing clinical trial participants’ recruitment and retention
  • Best practices to prepare for Plain Language Summary submission timelines

Simply fill out the form and download the white paper for free!

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