Image Repository

Clinion Image Repository is a medical imaging module built directly into the Clinion Electronic Data Capture (EDC) platform, designed for clinical trial teams that need to upload, de-identify, store, view, and export trial images within a single system. It supports DICOM, JPEG, PNG, and PDF formats across more than 10 imaging modalities, and uses AI-powered PHI redaction to remove patient identifiers automatically before images are stored. The module is intended for sponsors, sites, medical monitors, and regulators who require compliant, audit-ready imaging workflows without procuring or maintaining a separate imaging platform.

Every image uploaded to Image Repository is automatically linked to the corresponding subject, visit, and CRF page within Clinion EDC, eliminating manual reconciliation and data silos. Images are encrypted end-to-end and stored on AWS HealthImaging, with browser-based access available 24/7 across time zones without requiring software installation.

Five-Step Imaging Workflow

1. Upload: Medical images in DICOM, JPEG, PNG, or PDF format are submitted via a browser-based interface. Pre-upload validation checks for errors before submission.
2. AI PHI Redaction: Upon upload, AI automatically scans each image to detect and remove patient identifiers including name, date of birth, gender, site details, and embedded metadata. Redaction completes in under 30 seconds. For high-risk studies, optional human QC review can be enabled to verify de-identification.
3. Secure Cloud Storage: De-identified images are encrypted and stored on AWS HealthImaging, organized by subject, visit, and CRF page, with direct links to corresponding EDC records.
4. Visualization: Images are viewed and analyzed using a built-in DICOM viewer that supports MPR, 3D rendering, fusion workflows, and multi-image comparison, without requiring external PACS or additional software.
5. Export and Reporting: Individual images or batch exports can be downloaded on demand for sponsors, sites, and regulators. Comprehensive audit reports support inspection readiness.

EDC Integration Capabilities

• Single login for all trial data — imaging and EDC accessed through one account
• Real-time synchronization with EDC subject records
• One-click navigation from an image to the corresponding CRF page
• Direct image access from within eCRF pages
• Multi-image comparison within the EDC environment
• Unified audit trail covering both imaging and clinical data
• Report access available within the EDC interface

Supported Imaging Modalities

• CT (Computed Tomography)
• MRI (Magnetic Resonance Imaging)
• PET (Positron Emission Tomography)
• Ultrasound
• DX/CR (Digital X-ray / Computed Radiography)
• Mammography
• Angiography
• RT (Radiation Therapy imaging)
• Digital Pathology
• Additional modalities as required

AI-Powered PHI Redaction Details

• Detects PHI across all supported image formats: DICOM, JPEG, PNG, and PDF
• Removes patient name, date of birth, gender, site details, and embedded metadata
• Processing completes in under 30 seconds per image
• Optional human QC review available for studies requiring additional oversight
• Pre-upload screening catches errors before submission
• End-to-end encryption via AWS HealthImaging

Key Benefits for Clinical Trial Teams

• Faster study timelines: Automated redaction and direct EDC linking reduce image processing time from hours to seconds.
• Lower total cost of ownership: No separate platform to procure, validate, or maintain; no additional IT infrastructure or extra vendor contracts.
• Reduced compliance risk: Consistent AI-driven PHI removal and unified audit trails support inspection readiness without additional effort.
• Simplified site experience: Sites upload images in the same system used for data entry, reducing training requirements and context-switching.
• Complete data continuity: Every image is linked to its subject, visit, and CRF page from the moment of upload, with no gaps in the trial record.
• Global 24/7 access: Browser-based viewing allows sponsors, sites, and monitors to access de-identified images from any location at any time.

Image Repository is compliant with FDA 21 CFR Part 11, HIPAA, GDPR, ISO 27001:2013, and EU Annex 11. Clinion states that its AI tools are developed according to Responsible AI principles covering accountability, transparency, privacy and security, reliability and safety, and fairness.