AG Mednet Solution Benefits
AG Mednet’s Clinical Trials Imaging network is an easy-to-use tool, enabling investigator sites to import images from within their workflow, de-identify, complete a fully-validated transmittal form and compliantly (HIPAA, 21 CFR Part 11) transfer the images and associated data through a secure network directly to the sponsor or its designated imaging core lab. Key benefits include:

• Increased trial efficiency with faster delivery of the imaging data
• Enhanced data quality and reduced site queries
• Fully compliant audit tracking; validated de-identified studies
• Completed transmittal forms meeting IRB requirements
• Ability to run Adaptive and Eligibility trials
• Significantly reduced cost versus today’s standard courier shipments

AG Mednet Solution Efficiencies

1. Transport: AG Mednet’s transport compared to current courier methods is faster, more reliable, and less expensive. AG Mednet guarantees delivery directly to trial repository, and provides for persistence mechanisms that overcome obstacles such as network outages. Additionally, AG Mednet provides automated notifications allowing senders, core labs, and sponsors to be alerted as submissions are made. Savings: ~35% on courier costs.
2. De-Identification: AG Mednet provides the industry’s most advanced de-identification capability. Aside from being configurable per-protocol, and providing advanced validation for all entries, the system will not allow image exams to leave the sender’s computer until the exam is properly de-identified. Savings: reduction of queries, eliminate need for additional courier expense, reduction in unusable data.
3. Transmittal Forms: AG Mednet provides advanced transmittal forms with advanced field validation. The content of these forms, as well as any meta-data existing as part of the images can be delivered directly to an EDC system, subject tracking applications at core labs and sponsors. Savings: elimination of data entry tasks by either core lab or sponsor, reduction in queries due to unreadable or improperly filled form.
4. DICOM Clinical Trials Module: AG Mednet has implemented the DICOM Clinical Trials Standard, providing for additional, clinical trial dependent values to be stored with the image exams. This capability integrated with an EDC system provides for full connectivity and data exchange between both systems. Savings: reduction of data entry costs and staff responsible for keeping EDC systems updated.
5. Part 11/GxP Audit Logs: AG Mednet maintains real-time audit logs for all activities that occur on the network, including the submission of image exams, de-identification and forms. These logs can be provided at the end of the trial as part of the evidence of all submissions.
6. Metrics: Using AG Mednet for image submission provides sponsors with significant data that can be used to measure trial execution performance. Through a combination of data collection around baseline scans and timepoints, together with automated notifications and web-service distribution of submission data, sponsors using AG Mednet can begin to gather the type of metrics proposed by MCC –the Metrics Champion Consortium.