AG Mednet, a technology company for clinical trials, is launching Judi // Monitor to address a vital clinical trial process: the review and verification of subject data at the site. Site monitors are tasked with Source Data Review and Verification to assure that data is captured within a protocol-compliant manner. While this activity is most often conducted onsite, since the advent of the COVID-19 pandemic, onsite visits by external personnel at investigator sites has been largely prohibited.
Delivering a monitoring tool to meet clinical trial needs now, as well as anticipating a future where remote and virtual trials are far more common, Judi // Monitor takes advantage of the 21 CFR Part 11 compliant set of features and functions in AG Mednet’s Judi platform, providing 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 includes the following features:
Security and compliance-Encrypt patient records at all times and store in HIPAA/GDPR compliant environments.
Fast deployment and complete data access control-Deploy and configure quickly so sites can collect, de-identify and upload subject data, with complete control over access to subject information with all data audit-logged and reportable.
Source data reviews-Access all tools for source data reviews including real-time dashboards, reports, automated notifications, and an embedded query system with email notifications and calls to action.
PHI management-Utilize AG Mednet’s advanced de-identification functions to ensure compliance with international patient privacy regulations.
“COVID-19 continues to paint an increasingly complex picture for the clinical trial landscape. The need to mitigate disruptions that can result from delays and obstacles to site monitoring is clear,” said Abraham Gutman, president and CEO of AG Mednet. “We can no longer depend on CRA visits to investigator sites to ensure clinical data quality. Judi // Monitor is designed to keep important trials on track during unpredictable circumstances while meeting the needs of sites, monitors, and trial managers to ensure complete security and control throughout the process. This will be increasingly important as the number of remote/virtual trials grows.”
Judi // Monitoring joins AG Mednet’s suite of robust clinical trials solutions. AG Mednet offers automated workflow solutions with Judi // Imaging to securely collect and store clinical trial imaging data, Judi // Adjudication to manage end-to-end clinical event and endpoint adjudication workflows, Judi // DSMB to conduct data safety monitoring board activities and provide a consistent and reproducible DSMB process, and Judi // Eligibility to streamline central eligibility review workflows in trials.