Case Study: a major pharmaceutical company delivers 30+ translated informed consent forms ahead of schedule with Linguamatics

Enhancing Patient Understanding and Safety

A major pharmaceutical company faced the significant challenge of translating over 30 patient consent forms into 13 languages to ensure compliance with the stringent EU Clinical Trials Regulation. Any inaccuracies or delays in translation risked the rejection of their clinical trial application. They partnered with the vendor Linguamatics to address this urgent need for precise and timely language solutions.

Linguamatics implemented a robust language solutions framework that prioritized regulatory compliance, patient safety, and stringent quality control. This approach successfully delivered the translations in under eight days, which was ahead of schedule. The results for the pharmaceutical company included securing timely regulatory approvals, enhancing patient understanding and safety, and improving operational efficiency for their CNS clinical trial.