Clinical trials have become an increasingly global affair.
Translation and localization are necessary to accurately present the outcomes of these trials.
Never has translation been more important with its ability to not only affect huge financial consequences but also safety to humans. We are familiar with the Clinical Trial Regulation (EU 536/2014). When translation is taken into consideration from the beginning of a study, it is more likely that all resources can be more efficiently assigned, delays can be avoided, and the documentation provided will be readily understood within the cultural context.
We translate the following types of documents and can also test these for understandability and readability if they are already translated:
- Informed Consent Forms (ICFs)
- Patient Reported Outcome (PRO) forms
- Instructions for investigators
- Instructions for patients
- Patient records