Linguistic-validationWe provide Bulgarian linguistic validation services and Eastern European validation services to ensure that your translated clinical trial, health outcome or experience questionnaires will be clearly understood by those we interview.

Once the Bulgarian version or the version into any other Eastern European language of the clinical trial questionnaire has been created it needs to be assessed for clarity, intelligibility, appropriateness and cultural relevance.

To ensure the most accurate translations, two independent Bulgarian translators or two other Eastern European translators translate the clinical trial questionnaire. Once the translations are complete, a reconciled version is created which unifies the two versions. The next step in the process is back translation, which is done by a third independent translator who translates the reconciled version back into English to check its accuracy. From this process a final corrected translation is generated and reviewed by the relevant Bulgarian clinical staff.

Harmonization is an additional tool that may be used to provide consistency and uniformity if the project includes a number of different language translations. This ensures that the vocabulary and structure across all translations is consistent.

Finally, the clinical trial questionnaire goes through cognitive debriefing to complete the linguistic validation process.

The questionnaire may need to be culturally adapted and then the translation must be linguistically validated.

How the validation process works

Our linguistic validation consultant (Bulgarian language consultant or other Eastern European language consultant) will conduct cognitive debriefing interviews in Bulgarian or in any other Eastern European language with 5 to 10 patients or healthy subjects to assess whether the text of your questionnaire is straightforward and easy to read. Once the interviews are completed we provide you with an interview report. Any issues found in the text will be highlighted so that the quality of the questionnaire can be improved.

Our professional linguistic validation services guarantees that you are able to gather accurate and relevant data from patients or trial subjects.