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CTIS | Regulatory Submission

Last year was quite the regulatory adventure for European clinical trials! At the end of January 2022, the Clinical Trials Regulation came into effect, aiming to address the challenges in the pharmaceutical sector and create a harmonized and supportive environment for clinical trials within the EU.

A pivotal change introduced by this regulation is the Clinical Trials Information System (CTIS), an electronic portal simplifying the application process by centralizing all submissions. However, adapting to this system is no small feat—it demands experience and a deep well of know-how.

Our dedicated regulatory team here at SCOPE has invested substantial time and effort in a rigorous training phase, demonstrating unwavering commitment to meet submission deadlines and skillfully address RFIs. The outcome? Multiple successfully completed clinical trials now submitted via CTIS. We’re immensely grateful for their hard work and dedication. Their commitment ensures that we can navigate these regulatory changes effectively and continue delivering excellence in clinical research. Thank you!


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