Optimizing global compliance
Solutions to reach and maintain global regulatory compliance
The EUCTR mandates that all documents related to clinical trials, including informed consent forms, protocols, and patient information leaflets, be translated into the language of each participating country. This new regulation also mandates much shorter submission deadlines, bringing down timelines from months to weeks, creating additional complexity.
Accurate translations not only ensure compliance with EUCTR requirements but also enable participants to fully understand the trial procedures, potential risks, and benefits.
Additionally, translated materials foster inclusivity and help build trust among diverse patient populations, ultimately contributing to the success and ethical conduct of clinical trials in the European Union.
An industry expert language service provider can help sponsors and researchers navigate this complex regulatory landscape.