Medical Translation
Linguistic Validation
Translation and cultural adaptation of patient-reported outcomes (PROs), informed consent forms (ICFs) and other patient-centred documents.
I follow structured validation processes in accordance with the relevant regulatory and methodological guidelines (FDA PRO Guideline, EMA Reflection Paper on PROs, ICH E6 GCP (R2, R3), ISPOR Task Force Guidelines).
Clinical trials and study documents
Translation of study-related documents for clinical trials in Phase II to IV.
I ensure that formal requirements are met, scientific standards are upheld and terminology is consistent.
Patient information &
medical subtitling
Translation of clinical documents, patient information materials and consent forms, as well as subtitling for medical training and educational videos.
Technical accuracy, confident use of terminology and clarity are paramount.
Standards
I translate specialist medical and pharmaceutical texts on the basis of current guidelines and terminological standards. My translations are guided by the requirements for clinical research and regulatory documentation.
Clear structure, consistent terminology and technical accuracy are paramount.
Collaboration
Meeting deadlines is non-negotiable; quality is a given. The details of each project are agreed early on in the process and in a transparent way.
My translations are always reliable and accurate, even when projects are urgent.
Quality assurance and revision
Each and every translation is carefully proofread. I ensure that terminology is always consistent, and that the style and structure of the text are aligned.
For complex projects, there is also the option of an additional specialist revision by a second translator (in accordance with ISO 17100).