Translation and writing for clinical trials

We both know you need someone who offers  specialized knowledge and linguistic skills.

Someone who has full understanding of relevant regulations and procedures...

Here are some of the materials I work with for Life Sciences companies, Contract Research Organizations, Language Service Providers, and Medical Communication agencies that choose me as their partner:

Medical Translation
  • Clinical Trials

    • 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​

  • Regulatory Documentation​

    • Annex I – Summary of Product Characteristics

    • Annex II

    • Annex III – Labelling and Package Leaflet

    • Annex A

    • Annex IV

    • Annex 127a

  • Medical Devices​

    • Instructions for use (IFUs)

    • Any 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​​

    • Websites and apps

Do you need an English to Portuguese medical translator?

Medical Writing
  • ​Consent forms and patient information

  • Drug information like package inserts or user guides for medical devices

  • Patient information materials

  • Plain language summaries

  • Study summaries

  • Congress and meeting reports

  • Conference abstracts and posters

  • Manucripts and book chapters

  • News and press releases

  • Online content like websites and blogs

  • Slide kits and training materials

  • Systematic literature reviews​

Do you need a medical writer for your project?

Linguistic Validation
  • Clinical Outcome Assessment (COA) measures

    • Clinician-reported outcomes (ClinRO)

    • Patient-Reported Outcomes (PRO)

    • Performance Outcomes (PerfO)

    • Observer-Reported Outcomes (ObsRO)​

  • Patient diaries

  • Quality of Life (QoL) assessment tools

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

Do you need to translate and validate a questionnaire to be used in Portugal?

If you don’t see what you’re looking for, I might be able to help you or refer you to someone who will.