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.
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
Christelle Giroudet
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.
Ana Alvarez
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.
Sponsor
ICON
Content Partners
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