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We both know that your content needs to be translated by someone who offers you specialized knowledge, linguistic and translation skills, and full understanding of the relevant regulations and procedures.

Here are some of the materials I translate for Life Sciences companies and Clinical Research Organizations that choose me as their partner:

  • Adverse events-related
    documentation
  • Case report forms (CRFs)
  • Clinical trial protocols
  • Healthcare informational brochures
  • Informed consent forms (ICFs)
  • Investigator’s brochures (IBs)
  • Market research and surveys
  • Packaging and labeling
  • Patient questionnaires
  • Press releases
  • Product information: SmPCs, PILs, PSURs, and DHPCs
  • Promotional and informational leaflets for medical professionals
  • Regulatory approval dossiers
  • Standard operating procedures (SOPs)
  • Technical manuals and user’s guides
  • Training material​

I offer linguistic validation services for Clinical Outcome Assessments or Quality of Life questionnaires based on the steps recommended by ISPOR:

  1. Preparation
  2. Forward translation
  3. Reconciliation
  4. Back translation
  5. Back translation review
  6. Harmonization
  7. Cognitive debriefing
  8. Review of cognitive debriefing results and finalization
  9. Proofreading
  10. Final report
 
In addition to these steps, I facilitate the clinician review in collaboration with a clinician specialized in the field.
 
I can also assist you with eCOA integration if you’re interested in migrating the paper version to an electronic format.

Think I might be a good partner for your next project?

If you don’t see what you’re looking for, I might be able to help you or refer you to someone who will.
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© 2020 Ana Sofia Correia. All rights reserved. Portugal.