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Clinical Trials - Clinical trials require significant investment, involve a great deal of sensitive information and, as such, need to be handled in the correct manner.

Clinical Trials.

Clinical trials require significant investment, involve a great deal of sensitive information and, as such, need to be handled in the correct manner.

With so much at stake and given the levels of investment involved, choosing a company to undertake your clinical trial translation requires care and attention. You need to be sure that your demands are going to be met with the utmost professionalism from start to finish.
Our extensive experience in documentation for clinical trials includes:

  • clinical trial protocols and synopses
  • patient information sheets
  • informed consent forms (ICFs)
  • investigator’s brochures (IBs)
  • pharmacovigilance/serious adverse event (SAE) reports
  • discharge reports
  • investigational medicinal product dossiers (IMPDs)
  • SOPs
  • ethics committee and institutional review board (IRB) correspondence and opinions

Experience has taught us that to guarantee excellent quality and avoid errors, consistency of terminology in clinical trial translation is crucial, even more so than in other fields. To ensure consistency, we can use specific tools not only for a single project, but throughout your documentation. For more information, see our How we operate section or contact us to discuss your terminology needs.

Rest assured your clinical trial translation is in safe hands with Zebra.

 

Back Translation

What is it and do you need it?

A back translation of clinical trial documents is often required by ethics committees/institutional review boards.
A back translation will help you to assess certain aspects of the initial translation such as completeness, general meaning and accuracy.

Our back translations are performed by qualified translators who do not have access to the original source text. This way the end result will be authentic, given that the translator has not been influenced. As long as the meaning of the original is retained, the back translation can be considered accurate.

Declarations/Certificates

What are they?

A Declaration or Certificate is an official document signed by a Zebra translator/reviser which certifies that the translation is true, accurate, and complete. This certification is backed by Zebra’s solid reputation for unfailing quality and the experience of more than 15 years in business.

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