Case Study

IQVIA Language Solutions: Ensuring Timely and Accurate EU-CTR Submissions

IQVIA Language Solutions: Ensuring Timely and Accurate EU-CTR Submissions

Pages 1 Pages

Under the EU Clinical Trials Regulation, a pharma sponsor needed fast, accurate translation of informed consent forms (ICFs) for regulatory approval across 13 countries. IQVIA delivered over 30 ICFs in 13 languages within just 8 days, ahead of deadline. Their language solutions framework emphasized regulatory compliance, patient safety, and quality. Layperson translations ensured patients clearly understood trial risks and benefits, while rigorous quality controls maintained accuracy under tight timelines. The outcome: timely approvals, improved patient comprehension, enhanced safety, and more efficient trial operations for a CNS study.

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