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Discover the steps you need to take and the factors to take into consideration when approaching European Clinical Trial Regulation (EU-CTR) 536/2014. Find out how to:

  • Stay in compliance and out of trouble
  • Build buy-in from senior decision makers at your organization
  • Create a Quality by Design-based plan and implement best practices
  • And more



Tips for preparing clinical trial documents

Download your free tip sheet from TrialScope Disclose for your overview of what to expect with CTIS and the steps your organization can take to handle the new requirements, including:

  • Practical considerations for sponsors
  • Adopting a Quality by Design (QbD) approach for trial documents
  • Building on a QbD foundation
  • And more
Tips for preparing clinical trial documents

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