Multi-country clinical trial, MENA
- Challenge
- A pharma company running a multi-country clinical trial needed ICF and patient materials in Arabic for several MENA countries and in Turkish.
- What we did
- Linguists with clinical research experience translated the materials, followed by back-translation, reconciliation and a terminology check against the approved regulatory references.
- What made it work
- Linguists with clinical research experience on every document, with a second linguist review under ISO 17100
- Back-translation by linguists who had not seen the source, then reconciliation of every difference in meaning
- Terminology checked against the approved regulatory references before submission