Mrs Rachael Lee MITI

Thirty years of experience, providing French to English translation services to regulatory authorities, pharmaceutical companies, hospital research departments, CROs, NGOs, publishers, academic institutions and patient associations in Europe, Canada and the US.

Compliance with ISPOR requirements, PRO Consortium best practices, EMA/FDA guidance, eCOA best practices, EU templates, GCP guidelines and ICH recommendations.

FR-EN translation and revision services:

* Clinical trials (participant information sheets and informed consent forms, IRB/IEC correspondence and approvals, CRFs, clinical trial protocols/reports and statistical reports).

* Regulatory affairs (from drug/vaccine development to post-marketing) including MA applications, CTD, SmPC, PL, PSUR.

* Inspection/audit reports, site master files, SOP, manufacturing and packaging processes, Ph. Eur. control test procedures, etc.

* Access to medicines, epidemiological studies and patient-facing resources, particularly in oncology, HIV, hepatitis, diabetes, malaria, rheumatoid arthritis, cardiovascular diseases and haematology.

* Back-room translation services for FDA inspections.

* Language editing.


Linguistic Validation Consultant services (EN for the UK, FR to EN):

* LVC services for different country-same language projects (into EN-UK), including translatability assessments, cultural adaptation, cognitive debriefing, proofreading, review analysis and final QA.

* LV project management services, including concept elicitation interviews and concept elaboration.

* electronic COA implementation (migration and screenshot review).

* FR-EN back translation.

ITI membership category: MITI

Translation

French English
ITI Assessed

Specialisms

  • Clinical trials
  • Cosmetics
  • International development
  • Literature - Non fiction
  • Medicine
  • Oncology
  • Paediatrics
  • Patient facing materials
  • Pharmaceuticals
  • Preventive medicine
  • Psychiatry
  • Psychology
  • Public health
  • Skincare
  • Statistics
  • Veterinary science
  • Zoology

Associated skills

  • Adaptation
  • Editing
  • Proofreading
  • Revising

Technology

  • SDL Trados Studio

CPD achieved within last 6 years

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