Protecting Precision in FDA and EMA-regulated Translations
Why Language Scientific?
MCRA is a market-leader medical device, diagnostics, and biologics CRO and consulting advisory firm. Their translations are subject to high-stakes regulatory scrutiny, and often involve multiple versions from global clinical trial sites.
When MCRA needed highly accurate translations of patient-reported outcome documents and patient-facing instructions for a knee evaluation form and pain scale, they turned to Language Scientific’s deep medical expertise and technical proficiency.
As one of MCRA’s approved translation providers with a track record of success in medical translation and FDA/EMA-regulated processes, Language Scientific was already aligned with the project’s quality and compliance requirements.
The Problem
MCRA needed highly accurate translations of patient-reported outcomes and patient-facing instructions for a subjective knee evaluation form and an associated pain scale.
- There was no margin for error; translation accuracy was directly tied to regulatory compliance
- Clinical meaning had to remain intact. The evaluation form and pain scale required precise terminology to preserve the initial intention of the questions and instructions.
- Patient-reported outcomes raised the stakes. Inaccurate or vague wording could change a patient’s interpretation of the information, thus affecting data quality.
- Multiple versions made the project more complex. Back-and-forth e-mails during the scoping phase led to a version of the survey being dropped.
- The deadline was the deadline. Any corrections or clarifications had to be handled immediately, to avoid downstream delays.
Results
Regulatory-ready translations, aligned with the project timeline
- Translations preserved clinical intent and patient clarity
- FDA and EMA requirements were met
- Scope and version issues were resolved without missing deadlines
Actions Taken
- Translated the IKDC Subjective Knee Evaluation Form and the VAS Pain Scale with close attention to clinical intent
- Aligned deliverables with FDA and EMA translation requirements
- Identified and corrected a scoping issue involving a missing version of the survey instructions
- Applied specialized medical and regulatory expertise throughout the process
