• Overview
• Clinical Trial Services
• Imaging Protocol Development
• Site Credentialing and Training
• Image Data Management
• Image Standardization and Quality Control
• Sub-Specialty Image Interpretation
• Quantitative Image Analysis
• Statistical Analysis
• Data Transfer and Online Reporting
• Regulatory Aspects and FDA Submissions

Regulatory Aspects and FDA Submissions

MedQIA brings the essential specific expertise and experience needed to deploy imaging biomarkers in an FDA trial. MedQIA scientists have extensive publications on biomarker validation and a track-record in statistical analyses and reporting for FDA submissions. This includes software validation, data validity checks, quality control, and HIPAA and FDA 21 CFR Part 11 compliance reporting. MedQIA measurement tools have been validated in peer-reviewed animal, phantom, and human studies.