Understanding the new EU Clinical Trial Regulation (EU-CTR)

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

The EU Clinical Trial Regulation (EU-CTR)—EU Regulation No 536/2014—marks a transformative shift in how clinical trials are conducted and disclosed across Europe. Designed to streamline processes and increase transparency, EU-CTR brings both opportunities and challenges for trial Sponsors navigating the regulatory landscape.

One of the most significant changes is the mandatory use of the Clinical Trials Information System (CTIS) for all new submissions. This centralized portal aims to improve trial efficiency, however, adapting to CTIS and related redaction and disclosure requirements can be complex.

Certara helps Sponsors confidently manage the evolving regulatory environment with a comprehensive suite of transparency and disclosure services. From CTIS submissions to EU-CTR redaction and compliance with EMA Policy 0070, our experts guide clients through every step of the EU-CTR process.

Download our white paper:
“Mastering the EU-CTR and CTIS Submission Requirements” – this in-depth resource outlines the goals of the new regulation, provides practical guidance on CTIS implementation, and shares best practices to ensure a smooth transition.

What you’ll learn

A clear understanding of the CTIS (Clinical Trials Information System) and how it fits within the EU-CTR framework

Strategies for meeting CTIS submission timelines and managing the transition from previous systems

Guidelines for clinical trial data anonymization and EU-CTR redaction

Tips for improving participant recruitment and retention under the new regulation

Best practices for preparing Plain Language Documents and meeting EU-CTR submission requirements

About the experts behind the white paper

Honz Slipka

Senior Transparency Specialist

With a background in neuroscience and health IT, Honz leads innovation in clinical data privacy, EMA Policy 0070 compliance, and efficient trial disclosure. He helps bring clarity to complex EU-CTR processes through expert analysis and modern solutions.

Anaya Rehman

Senior Transparency Specialist

Anaya brings over a decade of experience in healthcare and pharma. She supports sponsors in meeting regulations including EMA Policy 0070, Health Canada Public Release of Clinical Information, and the EU Clinical Trial Regulation 536/2014, offering deep subject-matter expertise in CTIS submissions and redaction workflows.

Download the white paper

Simply fill out the form to access your free copy and get the insights you need for success under the EU-CTR.

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.