I am translator of pharmaceutical texts with more than 20 years of experience. My working languages are English and Latvian, but I also speak Russian and Spanish.
My experience is in the following fields:
Clinical trial documentation: translation, editing, compliance checking. Informed consent forms, clinical trial manuals, investigator contracts, product information leaflets, investigational drug labels, study protocols, advertisement posters, etc.
Regulatory documents: European Medicines Agency (EMA) workflow, Summary of product characteristics (SmPC), Patient information leaflets (PIL), scientific conclusions, application letters, QRD templates.
Linguistic debriefing and harmonization projects for clinical studies. PRO, EQ-5D instruments, forward and back translations.
Cognitive debriefing: patient interviews by phone and in person, evaluation of linguistic results.
Other medical and pharmaceutical products: medical devices, discharge letters, care plans, clinical assessments, tests & investigations, lab manuals, testing plans, pharmacopeia articles, microbiology equipment and procedures.
- Language translation English into Latvian
- Revision & proofreading
- Translation and cultural adaptation of Patient reported outcomes (PRO)
- Harmonization of EQ-5D instruments
- Cognitive debriefing interviews
- Quality assessment, style guide preparations
- Language Quality Assurance services
- Terminology checking, research, development of style guides
End clients include largest pharmaceutical companies: Johnson & Johnson, Pfizer, GlaxoSmithKline, Novartis, Sanofi, AstraZeneca, Abbott Laboratories, Merck, Eli Lilly, Grindex and others.
E-mail: firstname.lastname@example.org Phone: +44 753-575-3131
© 2017 Kaspars Melkis