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.
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.
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.
Judi for 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.
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.
Contact us today to learn more about how Judi can automate, expedite, and improve your clinical trials.Book a demo
The entire picture of the who, what, when, how and where of your process and all its steps
Management reports incluidng meeting attendance, document access and board member payments
Whether running a standard or modified process, you can get up and running in record time
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
Adjudication workflow solution for Clinical Endpoint/Event Adjudication
Eligibility workflow solution for Central Screening Committees/Eligibility Reviews
Monitoring workflow solution for Remote Source Data Review and Verification
Medical imaging workflow solution for Central Image Collection, Storage and Review
Qualification solution for Sponsors/CROs to Qualify Clinical Sites and eClinical Users
Workflow solutions for everything else: If You Can Map It, Judi Can Manage It