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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)

The new EU Clinical Trial Regulation (EU-CTR) is designed to streamline clinical trials, creating benefits for both patients and researchers. However, with the mandatory transition deadline of 1월 31, 2025, Sponsors face significant challenges in adapting to these regulations. Certara’s depth of expertise and comprehensive transparency and disclosure services are here to help you successfully navigate this evolving regulatory landscape.

Download our white paper to explore:

  • The goals and key implications of the new EU-CTR for those conducting clinical trials in Europe
  • A comprehensive understanding of the updated Clinical Trials Information System (CTIS)
  • Compliance strategies to meet the CTIS transition timelines
  • Guidelines for anonymizing and redacting clinical trial data
  • Proven tips for enhancing recruitment and retention of clinical trial participants
  • Best practices for preparing Plain Language Summaries within the new submission timelines

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

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