EMA Reports Progress with EU Clinical Trial & Orphan IT Systems

The European Medicines Agency says progress is being made with new IT systems for clinical trial and orphan designation applications in the EU. 

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Progress is being made with EU IT systems for clinical trials and orphans • Source: Shutterstock

The EU’s new Clinical Trials Information System is nearing the point at which it will be ready for audit to make sure that it is fully functional, after which it will be further enhanced in preparation for “go-live” sometime in 2020, according to the European Medicines Agency.

The CTIS, which encompasses a clinical trial portal and database, will constitute a single entry point for companies wanting to submit clinical trial applications and other trial-related data in the...

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