AG Mednet Unveils Judi // DSMB with Focus on Security, Automation in Clinical Trials
20 March 2019
BOSTON, March 5, 2019 /PRNewswire/ -- To build upon its mission of accelerating clinical trials and protecting sensitive trial data, AG Mednet has released Judi // DSMB, the first-of-its-kind automated workflow solution focused on the security and automation of data safety monitoring board activities throughout the life of a clinical trial.
Data Safety Monitoring Boards (DSMBs), which are created at the outset of a trial to perform periodic reviews, are managed today with little security. The process currently occurs across various platforms with little cohesion, dependability and security measures in place, posing a great risk to the integrity of unblinded clinical trial data. Judi // DSMB streamlines the process from meeting scheduling to data collection and aggregation, to distribution, form management, secure signatures and storage, maximizing efficiency and eliminating security vulnerabilities that could jeopardize a trial.
The platform provides CROs, sponsors and regulators the ability to have every communication between participants, as well as all documents and summaries, in a single, secure, audited environment with role-based viewing restrictions. The new platform is designed to streamline the coordination and conduct of DSMB activities in an easy-to-replicate manner. Judi // DSMB enables an accelerated and secure clinical trial process.
Judi // DSMB is designed with advanced dashboards, a reporting database and a report builder. The reports enable participants to see the state of all past, present and future meetings in a concise manner. The platform allows for the distribution of blinded and unblinded reports, as well as the ability to manage all real-time communications related to DSMB activities in an auditable, 21 CFR Part 11 compliant manner. Judi // DSMB can securely collect, transfer and store source data in any format.
"Judi // DSMB allows us to protect a very delicate process. Right now, DSMB activities are being handled across multiple, unsecure platforms," said Abraham Gutman, president and CEO of AG Mednet. "We've introduced a much-needed platform that CROs, sponsors, DSMB members and regulators can utilize to maximize efficiencies within processes that is both easy to use and secure."
AG Mednet also offers automated workflow solutions with Judi // Imaging, which is used to securely collect and store clinical trial imaging data in addition to Judi // Adjudication, which helps manage end-to-end clinical event and endpoint adjudication workflows.
About AG Mednet
AG Mednet is the leading quality compliance partner for image data management, as well as DSMB, endpoint and adverse event adjudication workflows. The company is a proponent of zero-delay clinical trials. The company has supported more than 1,300 global clinical trials. Dozens of adjudication protocols are being managed by sponsors and CROs using Judi. More than 60,000 registered users across thousands of investigator sites in more than 80 countries use AG Mednet to submit more than 17,000,000 images per month and adjudicate hundreds of events in projects sponsored by each of the world's top 20 pharmaceutical, biotech and medical device companies.
SOURCE AG Mednet