Judi // DSMB

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 process.

Our DSMB platform provides CROs, sponsors and regulators alike 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 standard configuration includes the following:

Dashboards→

Meeting countdown

Documents received / outstanding

Open document queries

Reports→

Board member payment report

Meeting attendance records

Document access report

Workflow→

Query system

Role-to-role communication

Branded stage-level eCRFs

Meeting notes and summaries

Reference Materials→

Charter

CVs

Conflict of Interest statements

Meeting schedule

Meeting agenda

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

  • Single location for DSMB core documents (e.g., charter, CVs, conflict of interest statements, etc.)
  • File access restricted by role
  • File access monitored with complete audit trail
  • Integrated communications system for different DSMB constituencies
  • Auditable communications between DSMB managers and document producers, and between board members & the DSMB manager
  • Real-time dashboards showing the status of source documents and processes

  • Blinded and unblinded data automatically segregated
  • Data access automatically restricted by role
  • Open and closed meeting notes indelibly part of the record
  • Comments collected electronically and automatically made part of the record
  • Meeting attendance collected electronically and made part of the record
  • Advanced dashboards, a reporting database and report builder, enabling participants to see the state of all past, present and future meetings in a concise manner

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.

It’s time to automate DSMB activities. AG Mednet’s platform is specifically designed to manage DSMB processes including:

  • Secure collection, transfer and storage of core data in any format, including SAS, xls, pdf, doc, ppt, and jpg
  • Distribution of blinded and unblinded reports
  • Ability to manage all real-time communications related to DSMB business in an auditable, 21 CFR Part 11 compliant manner

Contact us to learn more about how Judi // DSMB can help automate, expedite and improve outcomes in your clinical trial.