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Clinical Trials

Be assured that your clinical trials will be translated accurately

The progress of mankind is not conceivable without the progress of medicine. But in our tough times striving to save more lives and to find out clear strategies of patients management naturally led to the development of evidence-based medicine. To practice evidence-based approach we need data obtained within randomized controlled trials, both preclinical and clinical. While preclinical trials mainly require internal documentation for scientists and drug developers with the publication of a distillation of the study results, which allows one to conclude if there will be a clinical phase of the study, clinical trials conducted in humans involve a large number of people, both participants and study staff. Hence, the more documents within clinical trials require localization.

Our translation agency offers best localization services for the clients. We provide a three-step certified process — translation with editing and proofreading for all phases of clinical trials and for every target audience — patients, study staff, study sponsor, CROs, and regulatory authorities who approve the study and its results. Be sure we will engage the best medical translators for your success. Localization of documents from planning clinical trials till their end is necessary to create an investigational medicinal product dossier (IMPD) for drug approval in the target country.

We consider style and language compliance to make the documents understandable and appropriate for target audience. Our translators and editors use simple and clear wordings for people of any academic background in patient-facing documents (Informed Consent Forms, Patient Information Sheets, promotional patient materials, posters, etc.), science-oriented language for doctors and investigators in study file documentation (study protocols, clinical study reports, Investigator’s Brochure, Case Report Forms, etc.), and even officialese for legal and financial papers to be submitted to regulatory authorities and audit committees.

In our language translation company only highly educated specialists work on translations of such level of sophistication, and the cross-validation method is applied to texts of related topics. e.g., Clinical Study Agreement, has been translated by a legal specialist, will be edited by a medical specialist, and proofread by a certified linguist. Moreover, we provide back translation services, so necessary for our customers while validation of patient scales and questionnaires, and post-editing for machine translation texts that have poor readability without human editing and quality assurance. 

More information

Subject matters

  • biologics
  • biomedical and behavioural interventions
  • diagnostic strategies
  • treatment strategies
  • prevention strategies
  • drugs, small molecules, compounds
  • vaccines
  • implamentable medical devices
  • surgical techniques

Documents

Documents for investigators:

  • investigator’s brochure
  • study protocol
  • case report forms (CRFs)

Documents for patients:

  • patient information sheet
  • informed consent form
  • emergency cards

Documents for regulatory authorities:

  • study reports
  • reporting on adverse events,
  • PSUR, DSUR
  • audit inspection documents

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