Clinical Trial Translation Of Medication For Atopic Dermatitis

Client

The client was a pharmaceutical company that provides different healthcare solutions for all people around the world. It conducts different researches in order to advance the treatment of many conditions and diseases. The thing that makes it the best is that it has a vast range of research, development, and manufacturing facilities across the globe.

Problem

The client needed clinical trial translation. The customer requested TEP services for all documents that pertained to a clinical trial of Phase I trial of the medication spanning Russian-speaking countries, therefore the language pair is English–Russian. The client provided us with guidelines that should be followed. As for document types, they were Patient Welcome letter and Patient Brochure as well as Doctor-to-Patient Letter and Patient Study Guide. As an investigator is Russian-speaking, we should not forget about investigator documents as well. The overall problem is to adapt the text for patients to understand it easily and for investigators to conduct a trial right.

Solution

We involved two groups of translators, proofreaders, and editors for this project. One of the groups worked on Patient documents, the other group worked on Investigator documents. The overall process was as follows:

  • translation step and work of two pools of translators with a medical background,
  • editing step where the other two groups of editors worked,
  • proofreading step involving the additional two groups of proofreaders,
  • Quality Assurance step when our specialist thoroughly checked everything, and…
  • delivery in time.

Our linguists used glossaries and Translation Memory in order to provide consistency throughout the texts.

Result

With the help of high-quality clinical trial translation, the company conducted Phase I of the trial successfully. The linguistic feedback received both from patients and investigators showed that the readability and understanding were well within these respective target audiences. Now the company prepares new documents for conducting Phase II of this trial. When it will be done, they will forward us them for further linguistic performance.

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