To support the need for storage and streamlined access to data during and after a clinical trial, AG Mednet, quality compliance partner for image data submission and collection, has launched AG Mednet Storage—a Part 11 compliant repository with on-demand access to clinical trial image data.
Imaging intensiveclinical trials create a tremendous amount of data—several gigabytes per subject—and require storage for a minimum of seven years for regulatory compliance. AG Mednet Storage is a complement to AG Mednet’s quality enhancement products including AG Mednet Submission Quality & Compliance—the first automated quality assurance software built specifically to detect errors at the investigator site prior to data submission in order to reduce queries and accelerate clinical trial decision-making.
For sponsors, the specific benefits of the AG Mednet Storage offering include: secure, validated and scalable infrastructure; copies of image data and case report forms from sites delivered simultaneously to sponsors and core labs; automatic alerts when new images are sent with real-time access to submissions; aggregated data for querying by site, subject, timepoint and modality; on-demand access to post-trial copies of unaltered submissions for future use and aggregation with other trial submissions.
For core labs, AG Mednet Storage offers on-demand infrastructure scalability without increased capital or FTE investments; redundancy, disaster recovery and long term archival; management of remote access by outside readers; regional storage across Asia, Australia, South America, Europe and the U.S.; simultaneous delivery of image submissions to multiple locations.
The cloud storage solution also benefits academic core labs by offering to collect, quality control and store image exams through AG Mednet; review image data using the AG Mednet viewer, WADO compliant viewers, or download DICOM images directly to local workstations; real time notifications when new data is received; access to a rich worklist of available image exams and relevant Case Report Forms submitted by trial sites.
“AG Mednet is committed to providing technology solutions that enable breakthrough pharmaceutical advances through zero-delay clinical trials,” said Abraham Gutman, president and CEO of AG Mednet. “The ability to easily store and access image data in a Part 11 compliant, on-demand manner gives sponsors, CROs and AROs the flexibility to expand current offerings and increase revenue opportunity with no capital expense. When used with AG Mednet’s quality enhancement offerings, organizations no longer need to accept trade-offs when it comes to managing, storing and accessing clinical trial imaging data.”