Tag: CTIS clinical trial tracking

EU Clinical Trials Information System (CTIS) Explained

September 21, 2025

EU Clinical Trials Information System (CTIS) Explained Comprehensive Overview of the CTIS Portal for EU Clinical Trial Applications The EU Clinical Trials Information System (CTIS) is the cornerstone of the new centralized approach to clinical trial submissions and regulatory communication in the European Union. Developed and managed by the European Medicines Agency (EMA), CTIS is…

Clinical Trials in EU, Country-Specific Clinical Trials

How to Use the Clinical Trials Information System (CTIS)

August 19, 2025

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How to Use the Clinical Trials Information System (CTIS) Step-by-Step Guide to Using the Clinical Trials Information System (CTIS) Introduction: What Is CTIS and Why It Matters? The Clinical Trials Information System (CTIS) is the centralized EU portal established under Regulation (EU) No 536/2014 to support the submission, assessment, and supervision of clinical trials throughout…

CTA (Clinical Trial Application), Regulatory Submissions and Approvals