Our linguistic validation methodology has been developed to provide a conceptually equivalent and culturally-sensitive adaptation of PRO Instruments (Patient Reported Outcomes or Measures, previously indexed as Quality of Life or QoL) to clients involved in clinical trials.
We recognize that an individual approach to each project is essential, so we discuss your particular needs in advance. We adjust our linguistic validation procedures accordingly in line with the principles of good practice for the translation and cultural adaptation of PRO instruments recommended by the FDA and EMEA.
Some of the PRO instruments we validate are:
- Symptom Checklists
- Patient Diaries
- HRQL Measurements
- Visual Analogue Scales
- General Health Perceptions
At the end of each project you receive the final linguistically validated version of the PRO instrument with appropriately applied formatting in each language, along with a project summary report that highlights the issues encountered and their respective solutions.
The package also includes our company’s certification for providing a linguistically validated translation that is conceptually equivalent to the original.