Clinical Studies

Clinical studies are an important component in medical progress. They answer medical questions and verify the effectiveness and safety of medicinal products and medical devices. mt-g supports the parties involved in the process at contract research organisations and pharmaceutical companies and thereby indirectly also assists health ministries, ethics committees and Regulatory Affairs departments with such projects. Through professional translations, back translations, adaptations and reviews, our Clinical Studies project management team aims to support our clients in every phase of a study.
  • Subfields of expertise (selection)

    • Pre-clinical studies
    • Phase I-IV clinical studies (documents, reports, protocols)
    • Studies in all medical fields of expertise (for example oncology, cardiology, gastroenterology, gynaecology, ophthalmology and laboratory diagnostics)
  • Typical texts and documents for translations in the clinical studies field (selection)

    • Lay Summary according to article 39 EU Regulation 536/2014
    • Patient information sheets and informed consent forms, patient diaries, patient cards, documents for patient recruitment
    • Inspection reports
    • Study-specific technical documents: study protocols, study protocol summaries (synopses), SAE reports, case report forms (CRFs, eCRFs)
    • Ethics correspondence
    • Legal documents: study contracts, investigator agreements
    • Miscellaneous study-related documents: training materials, quality-of-life questionnaires, press releases
Your contact
Giulietta Toneatto
Team Leader Clinical Studies
Unsere Qualitätsstandards sind durch die tiefe Spezialisierung und
fortwährende Prozessoptimierung auf einem außergewöhnlich hohen Niveau.