Manage image worklists and generate interpretation reports for core labs or post-market surveillance teams
MDDX’s Image Lab Application provides complete visibility into the status of each image at core labs using the system. Sponsors and CROs can view the granular status of each processing step from Check-in to Image QC to Interpretation. Meaningful data visualizations show performance metrics for case processing and query disposition times.
Despite best-laid plans, ever-evolving trial demands make case prioritization a dynamic effort. New sub-studies, requests from regulators, and safety team requests can result in a constant reshuffling of the order of interpretation. The Image Workflow application gives you unprecedented visual control over where a case sits in the queue – and for designated roles, the ability to set the read order.
Imaging Core Labs should be blinded to the identity of the research site who submitted the images. The bias imparted by preconceived knowledge of a research site’s proficiency might have an impact on the scientific integrity of the trial. Moreover, Core Labs’ strength is image interpretation, not chasing down errant datasets from hospitals thousands of miles away. MDDX’s query management function acts as a blinded agent to allow the lab to query sites anonymously. MDDX’s staff acts as the monitor and facilitator, evaluating each query response for accuracy and sufficiency.
The Image Lab Application eliminates the black box by monitoring the lab’s compliance measures for you. All steps in the core lab’s workflow are represented in customizable, validated image interpretation eCRFs. The forms are built on the foundation of 21 CFR Part 11 compliance, with e-signatures, screenshots of results, and unalterable audit trails.