Judi in DSMB

Simplify Data Safety Monitoring Board and Data Monitoring Committee Activities

Pain point

Managing the collection of unblinded data, its distribution and ensuring that the right people have the right permissions is a very challenging process managed using email, file-sharing and other non-compliant systems.

Benefits

Automate DSMB workflows with a focus 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.

Collection, Scheduling, Distribution

A flexible workflow enabling the secure collection and handling of blinded and unblinded data, with functions to schedule meetings, distribute biostatistics reports appropriately to Open and Closed Meeting participants and the ability to complete remote electronic signatures on common meeting notes.

Facilitating Communication between Data Management, Operations, Bio Statisticians & Board Members

Judi in DSMB 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.

Maintaining Secure, Auditable, Compliant DSMBs

Providing 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, and the ability to manage all real-time communications related to DSMB business in an auditable, 21 CFR Part 11 compliant manner.

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Key Features

Dashboards

The entire picture of the who, what, when, how and where of your process and all its steps

Reports

Management reports including meeting attendance, document access and board member payments

Workflows

Whether running a standard or modified process, you can get up and running in record time

Reference Materials

From board charters, CVs, Conflict of Interest statements to meeting schedules and meeting agendas, you can store and make these materials accessible on a role basis

AI-Assisted Redaction

Judi’s proprietary AI-Assisted Redaction capability automatically detects potential inclusions of PHI and flags them for review, saving time and reducing regulatory risk.