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what we do
KONTEKST is a certified provider of translation services.
KONTEKST is a certified provider of translation services for global clinical research organizations, pharmaceutical companies, as well as law and consulting firms.
KONTEKST has been in existence since 2000, and specializes in translation services for contract research organizations (CROs), pharmaceutical companies, law firms, and consulting companies. We work with our Clients on a global level and we are among Approved Vendors for major global pharma companies. KONTEKST has the necessary tools and the know-how based on our 20+ years of expertise.
KONTEKST successfully passed an audit by Bureau Veritas Certification Polska for compliance with the industry standard ISO 17100:2015.
The international standard ISO 17100 is a quality standard which replaces the previous European standard PN-EN 15038 in providing detailed specifications for the translation industry.
The standard describes the processes, definitions and requirements for quality translation and localisation services and translation project management.
KONTEKST in numbers

- 250
language combinations - 8 of 10
largest Clinical Research Organizations are our clients - 300
pharmaceutical clients - 0.4%
complaint level - 40+
in-house team
Clinical Trial Protocol – a Real Challenge for Translators
The protocol is a key document for every clinical trial. It is fundamental to the entire research project, defines the objective and describes the design of the study as well as details of the applied methodology and methods of statistical analysis. It provides...
Why is the process of translating regulatory submissions so unique?
Translation of regulatory submissions is often perceived as a necessary evil by clinical trial management teams, because it involves considerable financial outlays. Therefore, persons responsible for regulatory submissions are usually under a lot of pressure. Despite...
Patient-reported outcomes (PRO) – challenges in the translation process in light of regulatory agencies’ requirements
Different language versions of study-related materials rate among the basic tools used to increase patient diversity in clinical trials. They are of particular importance because language barriers may prevent information about a conducted study from reaching potential...