Q&A with Novo Nordisk: Orchestrating Your Company’s Response to EU CTR
Novo Nordisk shares how to address some of the major process changes required by the EU CTR.Read More
EU CTR Challenges Sponsors and CROs To Get Their Houses in Order
EMA’s vision of a single source of truth for clinical trial information forces a major shift in how companies collect and store trial data and documents.Read More
What is CTR?
The EMA Clinical Trials Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the European Union (EU)/European Economic Area (EEA), with the highest standards of safety for participants and increased transparency of trial information.
What is CTIS?
The regulation harmonises the assessment and supervision processes for clinical trials throughout Europe, via a Clinical Trials Information System (CTIS) – a centralised portal and database for clinical trials. CTIS is the entry point to submit all the required data for a clinical trial following CTR, and is the interface between Sponsors and Member States.
How can I stay on top of CTR updates?
Subscribe to the EMA CTIS newsletter for updates on CTIS usage, key facts, tips, and reference materials.