How Technology and Subject-Matter Expertise Improved International COA Validation
A top-10 pharmaceutical company was struggling with the linguistic validation of Clinical Outcome Assessments across dozens of languages and multiple countries.
The client needed a partner that could manage a complex global workflow while meeting regulatory expectations from authorities such as the FDA and EMA. Language Scientific was selected because of its 25+ years of experience, 99.7% on-time delivery record, and proprietary technology built to support complex linguistic validation projects.
The Problem
The client needed to complete linguistic validation for multiple Clinical Outcome Assessments across dozens of languages and countries, while meeting strict regulatory, budget, and timeline requirements.
Key challenges included:
- Dozens of target languages across multiple countries, requiring consistent clinical meaning across every version.
- Limited budget, making it necessary to reduce unnecessary translation work without compromising quality.
- Tight submission timeline, requiring a faster workflow with no room for major errors.
- Complex validation requirements, including clinician review, usability testing, cognitive debriefing, and in-country review.
- Repeated terminology across COA instruments, which needed to be identified and managed consistently.
ACTIONS TAKEN
- Reused approved terminology and concepts where appropriate to improve consistency and reduce redundant work
- Applied Linguistic Validation and Cultural Adaptation methodology across every language and country
- Assigned specialized linguists and subject-matter experts to support clinical accuracy
- Used proprietary technology to accelerate project setup, QA, project management, and delivery
- Centralized translation management to reduce administrative costs
- Focused time and budget on the highest-risk areas of the project
- Ensured every document conveyed the same clinical message across languages and countries
