ICON's COA Linguistic Validation Leaders highlight the importance of Linguistic Validation and how equivalence should be a key focus during the development of Clinical Outcome Assessment translations.

Evidence generation on endpoints plays a key role in the value demonstration story. For the information captured in Clinical Outcome Assessments (COAs) to be useful, the critical data from these documents must be accurately collected and comparable across languages, cultures, and countries. We often see this process fail, not because the product is not doing well, but because the measure missed the point.

The globalization of clinical research has strong implications for outcomes measurement since psycho-modulated measures such as Patient-Reported Outcomes (PROs) or Clinician-Reported Outcomes (ClinROs) are commonly included in international clinical studies. Due to the sensitivity of such scales to culture, it is crucial to ensure that equivalence is addressed during the development of translations. This will allow data to be safely compared across countries and languages.

Key Topics Include:

  • What is Linguistic Validation and why is it important?
  • Overview of Linguistic Validation processes
  • Linguistic Validation versus translation
  • The different approaches to COA translations based on the nature of the COAs and planned use
  • Real examples of challenges encountered during Linguistic Validation

Who Should Attend?

  • Clinical Operations
  • COA Managers
  • Global Health Economics, Outcomes Research
  • Clinical Trial Protocol Design
  • Regulatory Affairs
  • PRO Development and Implementation
  • Global Market Access

Presenters

COA Linguistic Validation Leader
Language Services, Patient Centred Sciences
ICON

Christelle Giroudet has been working in the field of clinical outcome assessments for clinical research for over 25 years. She has extensive experience in her various roles in project management, proposal development, and commercial activities for linguistic validation projects.

COA Linguistic Validation Leader
Language Services, Patient Centred Sciences
ICON

Ana Alvarez has a Master of Arts in Translation and Terminology and over ten years of experience working in the clinical research industry. As Account Manager at ICON, she proactively develops new business opportunities and manages a portfolio of active clients handling client communications and client outreach.

Production Partner

ICON

ICON is a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients - reducing time to market, reducing cost and increasing quality.

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