Judi // Monitor
The time when we could take CRA visits to investigator sites for granted has drawn to an end. The global COVID-19 pandemic has forced us to rethink many procedures in light of the difficulties created in visiting hospitals to do source data review (SDR) and source data verification (SDV). While these monitoring activities may not altogether go away, there is a need to reduce visits on an ongoing basis, as well as to be prepared to eliminate them completely in cases of hospital emergencies.
That is why AG Mednet created Judi // Monitor, a unique solution for remote monitoring procedures.
Judi // Monitor takes full advantage of the 21 CFR Part 11 compliant set of features and functions in AG Mednet’s Judi platform. It provides the required workflows, security mechanisms, de-identification and HIPAA/GDPR storage requirements to meet the most stringent needs defined by international subject privacy standards.
Judi // Monitor standard configuration includes the following:
Records encrypted at all times both in transit and at rest
Site ability to delete records
All records stored in HIPAA / GDPR compliant environment
Advanced de-identification functions
Records received / outstanding
Open / Resolved queries
Record verification statistics
Audit logged real-time chat function
Embedded query system with email notifications and calls to action
Fast deployment and complete control around data access
Judi // Monitor can be deployed in less than two weeks and provides the necessary infrastructure enabling sites to collect, de-identify, and upload subject data. Sites always maintain control over who can see subject information and when this information must be removed from view. Access to data is strictly controlled, audit logged and reportable.
Source data reviews for clinical trials
Judi // Monitor provides all of the core functionalities necessary to carry out source data reviews. Real-time dashboards, reports, automated notifications, query capabilities and live chat features make the remote process effective, efficient and secure.
Judi is a proven, browser-based platform with more than 65,000 users in clinical sites in more than 80 countries.
How can you reduce clinical trial queries by more than 75%?
GET A DEMONSTRATION OF HOW AG MEDNET CAN:
Check whether scans were properly acquired at the site.
Check for compliance at the site prior to image submission.
Report protocol discrepancies before images arrive at the lab.
AG Mednet is the first platform to provide substantial enhancements to image submissions in clinical trials.