Echosens Quality Assurance Program for Clinical Trials with FibroScan®
Quality at Every Scan. Confidence in Every Result.
Echosens is the only company with an FDA-approved Letter of Intent to qualify LSM by VCTE® as a non-invasive surrogate endpoint in MASH clinical trials.
To support this goal and enable the potential replacement of liver biopsy, Echosens has developed a comprehensive quality management solution designed to ensure the consistency, reliability, and integrity of FibroScan® data across your clinical trial.
How Does Echosens Ensure Consistent and Reliable FibroScan® Data in Clinical Trials?
| DEVICE ASSURANCE Trial-ready devices—and confidence they stay that way |
OPERATOR ASSURANCE Qualified operators delivering consistent, high-quality exams |
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Ensure every device meets standards before site activation and monitor for changes that could impact data quality.
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Confirm certification, evaluate proficiency, and provide standardized training across study sites.
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| EXAM ASSURANCE High-quality data you can trust |
DATA ASSURANCE Secure, seamless management of your trial data |
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Central review identifies exam-quality issues, provides feedback, and supports corrective action when needed.
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Enable efficient global collaboration while maintaining data integrity, regulatory compliance, and traceability.
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Why Sponsors Choose the Echosens Quality Assurance Program?
| 1. Reduce variability across sites, operators, and devices | 2. Improve the quality and consistency of FibroScan® data | 3. Identify issues before they impact study endpoints | 4. Standardize performance across global clinical trial sites | 5. Deliver greater confidence in every FibroScan® endpoint |
Protect your FibroScan® data from site activation through study completion.
Dedicated White Paper
With clinical data, evidences and figures, this white paper illustrates how FibroScan® and its associated solutions are used by the Pharmaceutical Industry and Clinical Research Organizations for drug development purposes.
Frequently Asked Questions About FibroScan® Data Quality in Clinical Trials
The Echosens Quality Assurance Program (QAP) is a comprehensive framework designed to ensure the consistency, reliability, and integrity of FibroScan® measurements across global clinical trials. It combines device qualification, operator certification, exam quality review, and secure data management.
Quality assurance helps reduce variability between sites, operators, and devices while improving data consistency and confidence in study endpoints.
Echosens provides operator qualification, certification, proficiency assessment, and ongoing competency support to maintain standardized examination quality throughout a study.
Liver stiffness measurement with FibroScan® VCTE® is being actively developed and qualified for use in clinical research, with Echosens highlighting its FDA-approved Letter of Intent supporting qualification efforts.
