ARE YOU READY FOR EU CTR?
Now is a good time to review where you stand in your EU CTR readiness. TransPerfect Life Sciences can partner with you to prepare for the compulsory application of EU CTR that came into effect in January 2023.
Keep up to date with EU CTR insights from subject matter expert, Pierre-Frédéric Omnes
Learn how TransPerfect’s EU CTR solution can help support your drug development process by watching the video below.
EU CTR PREPAREDNESS
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the EU Clinical Trial Regulation (EU CTR) went live on January 31, 2022.
All trials currently in the scope of the EU CTR will have to end or transition to comply with the new regulation by January 31, 2025. Sponsors and clinical trial applicants will need to consider the upcoming expansion of EU CTR for new submissions as well as ongoing studies in order to prepare for its multiple operational impact. Here are some ways TransPerfect ensure a successful adjustment:
SOPs
Updating SOPs and work instructions for matters affected, including impact on vendors contracted for trial-related activities
Systems
Managing submission activities using the new EU Portal, Clinical Trial Information System (CTIS), while accounting for evolving transparency rules
Timing
Optimizing translation management for expedited handling of ethics/regulatory queries (up to 12 calendar days turnaround time)
Documents
Transparency strategies regarding disclosure principles (authoring, redacting, and deferring setup for study documents submitted at the end of the trial)
Training
Training teams to evolve operational practices (clinical, medical, regulatory, transparency, etc.) to the new framework
Studies
Piloting studies under EU CTR to confirm/adjust implementation strategies as needed
Strategies
Assessing the impact on organizations and planning readiness strategies based on development portfolios
WHITE PAPER
Get the latest insights on EU CTR operational considerations and challenges in our latest white paper.
Download White Paper
MORE RESOURCES
Investigational Medicinal Products: Labeling Changes and Their Implications
Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider
Understanding the Scope and Pain Points of Study Start-Up - Part 2
Get in Touch
Discover how TransPerfect Life Sciences’ team of experts can support you in preparing for the EU CTR changes. Reach out today to chat with our regulatory consultant, Pierre-Frédéric Omnes.
Contact us