Judi // DSMB, an AG Mednet SaaS offering, provides the first automated workflow solution in the clinical trial industry, and focuses on the security and automation of data safety monitoring board activities throughout the life of a clinical trial, providing a consistent and reproducible DSMB/DMC process.

Our DSMB 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 environment with role-based viewing restrictions and complete audit trail.

Judi // DSMB is the first integrated, 21CFR Part 11 compliant system to enable full process automation, tracking and scheduling for data safety monitoring boards and DMCs. Capabilities include:

Current state of DSMBs

Data Safety Monitoring Boards (DSMBs) are created at the outset of a trial to perform periodic reviews of trial progress and results. Boards typically meet twice or four times per year to review data which has been prepared in advance by a group of biostatisticians with access to the most sensitive data being produced in the trial. The biostatisticians receive both blinded and unblinded data – including EDC, ePRO, IVRS/IWRS, central lab results, and event adjudication reports and data sets – from a variety of systems being managed by multiple organizations.

DSMBs are often managed with basic, low-level tools including email and file-sharing products such as SharePoint and Dropbox that may present security vulnerabilities. Communication with members of the board occurs via email, and the evaluation documents are shared either via email, cloud storage systems or via courier, with no audit trail. The collection of attendance records is handled manually after every meeting, and the notes and conclusions reached by the board are created and filed for future use, and often stored as hard copy documents.