ELIA ND Athens: Life Sciences and Localization, a Complex World

Marianna Athanasopoulou – ORCO

This session is dedicated to the different sub-verticals within Life Sciences and more in particular pharmaceuticals and clinical trials. LSPs who want to enter this highly-regulated market have to be aware of its complexity and stringent demands and enter the Life Sciences arena well-prepared. Marianna Athanasopoulou from ORCO discussed different areas within pharmaceuticals/clinical trials and also the current EU regulatory requirements for each of these verticals.

• ORCO was founded in 1983, entered life sciences (LS) sector in 1997
• What differentiates LS translation from other translation sectors:
  • Highly regulated and formalized environment
  • Quality and accuracy are of critical importance
  • Cultural and linguistic peculiarities
  • Quick turnaround times due to the narrow timeframes for regulatory submission and approval of translations
  • Complex workflows and methodologies
• Three main categories:
  • Medical devices
  • Pharmaceuticals
  • Clinical trials
• EU regulatory requirements for pharmaceuticals (European Medicine Agency – EMA):
  • All documentation must comply with the EMA Working Group on Quality Review of Documents (QRD) templates, available in 25 EU language plus Icelandic and Norwegian
  • Strict timeframe of 20 calendar days for submission, validation and finalization of translated version of all documents

  EU regulatory requirements for clinical trials:

  • All patient-facing clinical trial documentation needs to be translated into the language of the trial population
  • European Clinical Trials Directive 2001/20/EC
  • Good Clinical Practice Directive
• Translation process and management:
  • Use a consistent and formal process
  • Select and train translators
  • Consult with healthcare professionals
  • Review of translation by a second person (medical reviewer)
  • Attempt to achieve direct involvement of the end client
• Types of content – regulatory documents:
  • Product information
  • Labeling
  • Pharmacovigilance (collecting data on drug safety)
  • PRO instruments, Quality of Life Scales and Questionnaires
  • Informed Consent Forms
  • Protocols
  • Investigator’s brochures
  • Patient and clinician education materials
  • Patient diaries, symptom checklists
  • Adverse events
  • Case report forms
  • Synopses
  • Clinical research and medical reports
• Types of content – sales and marketing:
  • Websites
  • Training / e-learning materials
  • Marketing communications / press releases
  • Promotional materials
• Processes:
  • TEP & QE/Review (TEP = translate, edit, proofread)
  • SME review (SME = subject matter expert)
  • FWD Translation 1, FWD Translation 2, Reconciliation, Back Translation, Back Translation Review, Comparative Review
  • Cognitive debriefing / pilot testing
  • Screenshot review, in-context review
  • Bug reporting and fixing
• Back translation is mandatory in some countries, but not in others
• Regression: verification of the correct implementation of all corrections and delivery of final files to the client
• Translation process in LF is 3 to 5 times more expensive than standard translation (in other industries)