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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

as required by the EU Clinical Trial Regulation (CTR) to ensure the safety for participants and increased transparency of trial information among CROs, sponsors and regulatory authorities.

  • Adverse events documentation

  • Case Report Forms (CRFs)

  • Clinical study agreements

  • Clinical trial protocols

  • Informed consent forms (ICFs)

  • Investigator’s brochures (IBs)

  • Patient instructions and information

  • 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.

  • 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

Regulatory documentation

as required for 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

When applicable:

  • Annex IV

  • Annex 127a

Linguistic Validation

  • 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.

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