AG Mednet Solution Benefits
AG Mednet’s Clinical Trials Image Submission Service enables investigator sites to import images from within their workflow, apply automated data checks and quality control modules, and transfer the images and associated data through a secure, fully-managed network directly to the sponsor or its designated imaging core lab. These exclusive submission quality modules include DICOM de-identification, Pixel de-identification, fully validated Case Report Forms, edit checks to ensure consistency of image and non-image data, and others which are modality or therapeutic area specific, such the collection of virtual histology files and non-DICOM image transfer logic. Key benefits of the AG Mednet solution include:
- Guidance for trial coordinators in building compliant timepoint submissions
- Enhanced data checks prior to submission
- Reduced site queries
- Validated, protocol-specific de-identification completed at the site
- Fully compliant audit tracking
- Validated, electronic image transmittal forms
- Ability to run Adaptive and Eligibility trials with extremely tight turnaround timelines
- Guaranteed delivery of images and image-related data with delivery confirmation
- Increased trial efficiency with faster delivery of the imaging data
- Significantly reduced cost versus courier shipments
AG Mednet Solution Efficiencies
- Quality Enhancement Tools: AG Mednet provides advanced quality compliance tools that greatly reduce the need for queries back to investigator sites. These tools include real time validation of de-identification parameters and electronic transmittal form fields, pre-population of transmittal forms with image header fields and reduction in the number of entries required by investigator sites. AG Mednet’s powerful and user-friendly workflow management capabilities help senders to complete their required tasks so the data they send is complete, compliant and ready to be interpreted. Other modules include collection of IVUS Virtual Histology files for proper image rendering and non-DICOM image data submission workflow.
- 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. Benefits: reduction of queries and processing delays, compliance with patient privacy regulations, and reduction in unusable data.
- Pixel De-Identification: AG Mednet provides the only capability in the market to eliminate patient identifying information that is part of the images themselves. This occurs at the investigator site, prior to submission, and ensures not only full compliance with national patient privacy laws and regulations, but also ensures that this process is completed by the senders and not by the receiving core labs.
- Transmittal Forms: AG Mednet provides electronic 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. Forms and forms data are indelibly linked to the images, so there will never be a lost or discordant form. Benefits: elimination of data entry tasks by either core lab or sponsor, reduction in queries due to unreadable, improperly filled or missing form.
- 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. Benefits: Elimination of many common opportunities for errors at the site, reduction of data entry costs and staff responsible for keeping EDC systems updated.
- Transport: AG Mednet’s transport compared to current courier or alternative electronic 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. Benefits: Higher utilization rates and lower frustration levels for site users, reduction in effort for recipients who no longer have to import images into their image management systems, greater visibility to the transport process for all.
- Real Time Notifications: AG Mednet provides flexible and powerful event notification functionality, enabling all trial stake-holders to be kept up to date with image and transmittal form submissions from investigator sites. Through this capability, trial coordinators, monitors, project managers and sponsors can be advised when submissions have started, when they have arrived at different repositories, and when they are in transit. Furthermore, these notifications contain all the information necessary to know which subject and timepoint data has been delivered. Through this mechanism eligibility trials with aggressive timelines can track all submissions and inform sites of all pertinent inclusion/exclusion decisions.
- 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.
- Metrics: Using AG Mednet for image submission provides sponsors with significant data that can be used to measure trial execution performance. With the combination of data collection around baseline scans and follow-up timepoints, together with automated notifications and web-service distribution of submission data, sponsors and core labs using AG Mednet have access to very powerful performance metrics. Many of the data points generated by the AG Mednet platform are in line with the metrics specified by the Metrics Champion Consortium (MCC).