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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.

Services

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)

    • Lay summaries

    • Patient Information Sheets (PIS)

    • Patient recruitment materials

    • Pharmacological studies

    • Scientific publications (papers, posters, abstracts)

    • Standard operating procedures (SOPs)

    • Study reports​

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  • Regulatory Documentation​

    • Annex I – Summary of Product Characteristics

    • Annex II

    • Annex III – Labelling and Package Leaflet

    • Annex A

    • Annex IV

    • Annex 127a

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  • Medical Devices​

    • Instructions for use (IFUs)

    • Accompanying information

    • Labeling particulars

    • Summary of safety and performance

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  • Education & Promotional Materials​

    • Marketing and advertising pieces

    • Patient education resources

    • Plain language materials

    • Press releases

    • Product brochures and catalogs

    • Training materials​​

    • Websites and apps​

Case studies:
Training materials for healthcare professionals and caregivers on child mental health
Research study deliverables of a project focused on developing assistive technology
Product information for marketing authorization application (SmPC, PIL, and labeling)
Patient education materials designed to promote digital and health literacy in older people
Medical device Instructions For Use (IFUs)

Do you need specialized medical translation?

Medical Writing

  • For patients and caregivers:

    • Clinical trial lay summaries

    • Disease awareness campaigns

    • Health brochures and pamphlets

    • Health newsletters

    • Medication adherence materials

    • Participant information sheets and consent forms

    • Patient education materials

    • Patient support program materials

    • Patient testimonials and success stories

    • Plain language summaries for publications

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  • For healthcare professionals and researchers:

    • Clinical study reports

    • Conference and meeting minutes

    • Journal article summaries

    • Scientific posters and presentations

    • Slide decks and training materials

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  • Communication and outreach:

    • Blog posts

    • Expert opinion pieces

    • Infographics and visual aids

    • News and press releases

    • Press kits

    • Social media campaigns

    • Thought leadership articles

    • Webinar scripts and materials

    • Website content

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

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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.

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