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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 Contract Research Organizations that choose me as their partner:

Clinical Trials
  • Adverse events documentation

  • Case Report Forms (CRFs)

  • Clinical study agreements

  • Clinical trial protocols

  • Informed consent forms (ICFs)

  • Investigator’s brochures (IBs)

  • Patient Information Sheets (PIS)

  • Patient recruitment materials

  • Pharmacological studies

  • Plain language summaries*

  • Scientific publications (papers, posters, abstracts)

  • Standard operating procedures (SOPs)

  • Study reports

* Lay summaries must be published in the language of each country where the trial took place no later than 1 year after trial completion.

Regulatory documentation

Required by the European Medicines Agency (EMA) for any centrally authorized product

  • Annex I – Summary of Product Characteristics

  • Annex II

  • Annex III – Labelling and Package Leaflet

  • Annex A

  • Annex IV

  • Annex 127a

  • Instructions for use (IFUs)

  • Information supplied (for self-testing or near-patient testing devices)

  • Labeling particulars

  • Summary of safety and performance (for class III and implantable devices)

Education/Promotional Materials
  • Marketing and advertising pieces

  • Patient education materials

  • Press releases

  • Product brochures and catalogs

  • Training materials

  • Website content

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

Linguistic Validation

I offer linguistic validation services for:

  • Patient diaries

  • Patient-Reported Outcomes (PROs) measures

  • Quality of Life (QoL) measures

  • Clinician-reported outcome (ClinRO) measures

  • Observer-reported outcome (ObsRO) measures

 

According to well-published methodology and industry guidance (ISPOR and ISOQOL):

  1. Preparation

  2. Forward Translation

  3. Reconciliation

  4. Back Translation

  5. Back Translation Review

  6. Harmonization

  7. Cognitive Debriefing

  8. Review and Finalization

  9. Proofreading

  10. Final Report

I can also assist you with eCOA integration if you’re interested in migrating the paper version to an electronic format.

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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© 2021 Ana Sofia Correia. All rights reserved. Portugal.