Clear Consent: How Conformal Medical Ensured Accuracy in Patient Documents
Why Language Scientific?
Conformal Medical, a medical device company specializing in next-generation left atrial appendage occlusion technology for atrial fibrillation (AFib), develops innovative solutions that improve patient outcomes and safety.
Within its clinical research group, Conformal Medical required accurate, patient-facing translations to support global clinical trials. Kurt Lang, Clinical Research Associate, was referred internally to Language Scientific by another team member who had previously worked with them successfully.
The Problem
Conformal Medical needed two Informed Consent Forms (ICFs) translated into U.S. Spanish for a clinical trial. Because ICFs are patient-facing documents, accuracy was absolutely critical to ensure participants understood the nature of the trial and gave informed consent.
The challenges included:
- Translating highly sensitive, patient-facing content with 100% accuracy
- Ensuring terminology was both medically precise and understandable for patients
- Meeting tight clinical trial timelines without bottlenecks
Conformal Medical required a partner with proven expertise in medical device terminology and experience managing critical clinical trial documentation.
ACTIONS TAKEN
- Delivered expert Spanish translations of sensitive, patient-facing ICFs
- Applied deep medical and device-specific expertise to ensure precision
- Conducted upfront fact-finding to assign the most qualified linguist
- Maintained clear and effective communication, avoiding bottlenecks
- Ensured a smooth, turnkey process that supported critical trial timelines
“Everything was accurate, timely, and within budget. We chose Language Scientific over our internal IRB because it was more expeditious and we trusted their medical expertise.”
— Clinical Research Associate, Conformal Medical
