Applied Clinical Trials
AG Mednet, a technology company automating and increasing data quality for clinical trials, has announced an expansion to its Submission Quality and Compliance (SQC) Toolkit. The Judi-based integrated image quality control (QC) product functionality gives core laboratories, CROs, and sponsors the most complete and powerful capability to manage site image submissions in record time. Judi is an AG Mednet technology platform designed and built from the ground up for the purpose of managing collaboration activities between different constituencies in the clinical trial ecosystem.
The growth of Judi's SQC toolkit, a component of every Judi // Imaging deployment, includes the newly released DICOM and exam editor which, as a first in the industry, provides powerful tools enabling advanced QC to be completed on medical image submissions. The configurable graphical editor enables not only the 21 CFR Part 11 compliant replacement of DICOM tag content with input validation but allows users to graphically reorganize instances and series throughout an exam, including the creation of new series and visual modification of series boundaries. Judi's DICOM and exam editor provides extensive exam navigation functions, undo capabilities, special features to handle PHI in a compliant manner and the ability to require electronic signatures for audit trail purposes.
Judi's entirely web-based and full featured-medical image viewer is also a component of the SQC toolkit and is integrated into the platform's powerful electronic case report forms (eCRF) system. With Judi // Imaging, radiologists and image reviewers have the ability to mark images and automatically complete eCRF fields. Through the robust intra-form workflow capability, clients can implement complex exam review processes that fit the particular needs of their trials.
"The combination of the newly released DICOM and exam editor together with its web-based viewer and the highly utilized SQC-based automated site-wide quality checks are the foundation of the first-in-market integrated approach to quality in trials using imaging data analysis," said Abraham Gutman, president and CEO of AG Mednet. "We are confident this upgrade will greatly enhance image management operations from the largest imaging CRO to the smallest clinical trial reading service as well as sponsors interested in ‘collect and hold' trials. Judi // Imaging manages clinical trial images through their entire lifecycle, in one platform that is all-inclusive and the proven system of choice."