Are You Ready for EU Clinical Trials Regulation 536/2014 (CTR)?

Prepare for the EU Clinical Trials Regulation (CTR) 536/2014 with PrimeVigilance’s expert guidance to navigate the new regulatory landscape effectively.

With extensive experience in regulatory transitions, PrimeVigilance offers comprehensive support for the EU-CTR’s requirements, including transparency and reporting obligations, updated safety reporting protocols, and enhanced patient protections. This case study illustrates PrimeVigilance’s strategic approach, from specialized working groups and detailed action plans to tailored training modules and procedural updates, ensuring clients achieve seamless compliance and operational efficiency throughout the transition. Download the full flyer to see how PrimeVigilance’s proactive strategies support clinical trial success under the new EU-CTR framework.

 

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