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Clinical Trial Data Sharing Under EMA Policy 0070

The landscape of clinical data publication is evolving rapidly. European Medicines Agency’s (EMA) Policy 0070 requires sponsors to publicly disclose clinical data for medicinal products in the European Union. It was suspended after Brexit and the COVID-19 pandemic. With the 2023 Policy 0070 relaunch, pharmaceutical companies face new challenges and opportunities in data transparency and disclosure.

When it comes to clinical trial data, regulators seek maximal data utility whereas patients and sponsors seek maximal patient privacy.
Current pharmaceutical industry standards of clinical data protection methodologies

This white paper explores the latest developments from the EMA and offers insights for sponsors navigating clinical data sharing. Discover how to balance data utility with data protection, streamline your submission process, and comply with regulatory requirements.

Submit the form to download your copy and streamline your approach to clinical trial disclosure. You’ll learn about:

  • The new Anonymization Report Template and its impact on protecting patient privacy
  • Industry trends in data treatment for sensitive information
  • Certara’s innovative solutions for efficient Policy 0070 compliance

Why partner with Certara?

Our Clinical Trial Transparency & Disclosure team offers cutting-edge solutions to streamline your Policy 0070 submissions, ensuring compliance while protecting sensitive data. Our tech-enabled experts can help you navigate the complex regulatory landscape and achieve your submission goals!

 

Learn how to save time and resources while publicly disclosing clinical trial data

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