Judi // Adjudication is a cloud-based platform built to manage end-to-end clinical event and endpoint adjudication workflows. Judi // Adjudication is designed from the ground up to support investigator sites, CROs, data managers, CEC members and sponsors who submit, collect, manage, organize and adjudicate clinical endpoint data.

Judi // Adjudication Benefits→

Judi // Adjudication is an integrated SaaS platform serving several constituencies, optimizing tasks while ensuring the quality of the data in the system. These stakeholders benefit from the use of Judi in the endpoint adjudication process.

Investigator Sites

Trial coordinators around the world benefit from an intuitive interface that facilitates completing the collection of event-specific documents, deidentifying them and submitting them for review and dossier aggregation. A powerful query management system together with a highly configurable notification capability ensures that tasks don’t linger and processes can move efficiently.

CRO Reviewers & Data Managers

Trial managers take advantage of a global view of all their projects, seeing at a glance the state of every event in the system. Additionally, tools to QA documents, send them for translation, aggregate them into dossiers and manage their adjudicators’ workload enable the managers to keep processes running efficiently. With an ability to communicate directly with sites as well as adjudicators and committees, CROs can for the first time keep track of their entire endpoint adjudication workflow and report on the status of all activities at the push of a button.

Adjudicators & Clinical Event Committees→

Judi // Adjudication provides adjudicators with robust dossiers and advanced eCRFs, enabling them to perform their evaluations and vote, as well as an ability to request additional information from the trial manager. Adjudicators can work asynchronously and, if desired, can be provided with an ability to reevaluate their decisions under circumstances defined by the sponsor and the CRO.

Clinical Event Committees→

The efficiency of clinical event committees is paramount. Committee chairs can see discordance at a glance and determine the main areas of discussion necessary for the disposition of every event. Judi // Adjudication provides highly dynamic dossiers containing live indexes that enable members to access all pertinent information at a glance. With an ability to have real time chat functionality with full audit trails, CEC meetings run smoother and all necessary forms as well as attendance are completed at the same time.

Sponsors→

Through the use of custom roles, sponsors can walk the fine line between knowing the general state of their endpoint adjudication projects and maintaining a barrier that avoids introducing bias into the process. Judi // Adjudication can deliver a variety of reports including FDA compliant closeout packages with all the required details to ensure proper regulatory filings.

Judi Benefits

Judi // Adjudication is an integrated SaaS tool serving several constituencies, optimizing tasks while ensuring the quality of the data in the system. These stakeholders benefit from the use of Judi in the endpoint adjudication process.

Investigator Sites

Trial coordinators around the world benefit from an intuitive interface that facilitates completing the collection of event-specific documents, deidentifying them and submitting them for review and dossier aggregation. A powerful query management system together with a highly configurable notification capability ensures that tasks don’t linger and processes can move efficiently.

CRO Reviewers & Data Managers

Trial managers take advantage of a global view of all their projects, seeing at a glance the state of every event in the system. Additionally, tools to QA documents, send them for translation, aggregate them into dossiers and manage their adjudicators’ workload enable the managers to keep processes running efficiently. With an ability to communicate directly with sites as well as adjudicators and committees, CROs can for the first time keep track of their entire endpoint adjudication workflow and report on the status of all activities at the push of a button.

Adjudicators & Clinical Event Committees

Judi // Adjudication provides adjudicators with robust dossiers and advanced eCRFs, enabling them to perform their evaluations and vote, as well as an ability to request additional information from the trial manager. Adjudicators can work asynchronously and, if desired, can be provided with an ability to reevaluate their decisions under circumstances defined by the sponsor and the CRO.

Clinical Event Committees

The efficiency of clinical event committees is paramount. Committee chairs can see discordance at a glance and determine the main areas of discussion necessary for the disposition of every event. Judi // Adjudication provides highly dynamic dossiers containing live indexes that enable members to access all pertinent information at a glance. With an ability to have real time chat functionality with full audit trails, CEC meetings run smoother and all necessary forms as well as attendance are completed at the same time.

Sponsors

Through the use of custom roles, sponsors can walk the fine line between knowing the general state of their endpoint adjudication projects and maintaining a barrier that avoids introducing bias into the process. Judi // Adjudication can deliver a variety of reports including FDA compliant closeout packages with all the required details to ensure proper regulatory filings.

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

Technical Capabilities

Workflow

Create customized workflows per event type, even within a single protocol or program

Electronic Case Report Forms

Enable eCRFs with advanced edit checks and data validation capabilities at any point in the process

De-Identification

Integrated tools enabling removal of protected health information (PHI) from document submissions

Query Management

Manage all event-related queries within the system and keep a log of all interactions

Notifications

Advanced email and web-service notifications to users based on their role

Audit Logging

Robust and compliant audit logging of all actions within Judi

Medical Imaging

Upload, de-identify, store and review medical images as part of endpoint or event submission

Role-to-Role Communications

In addition to the integrated query management, Judi enables specific roles or groups to chat about a case or a project within Judi, while keeping a detailed audit log of all interactions

Robust Reporting Infrastructure

Library of commonly-used reports to provide visibility to a given project’s status or status across a number of projects in a program. Judi also enables users to create their own ad hoc reports.

Dashboards and Worklists

Standard and customizable dashboards to help users visualize worklists, case status and project health.

Integration

Communicate with EDC and safety systems through a well-defined web-services API

Features by Activity

Protocol Management: Data and Tools for CRO Reviewers and Data Managers

  • Assemble dossiers and include/exclude
  • Documents submitted by sites either electronically or physically
  • CRO-generated notes
  • Translations
  • Queries
  • De-identify documents as needed
  • Open, respond and close queries to sites and adjudicators
  • Move process forward
  • Distribute dossiers to individual adjudicators
  • Distribute dossiers to AROs
  • Retrieve documents from sites
  • Call back dossiers
  • Run QC events and report on variance
  • Generate and run reports and output to Excel, CSV, Word or PDF
  • See at-a-glance state of all events through protocol-defined dashboards
  • Review audit logs
  • Track events and documents throughout the adjudication lifecycle
  • Generate regulatory-compliant outcome reports
  • Generate payment reports for adjudicators
  • Communicate with sites, adjudicators, CEC and sponsor with fully audited interactions

Document Submissions: Easing Source Data Submissions

  • Upload any document type including medical images
  • De-identify documents
  • Fill out smart eCRFs
  • Parse large or combined files into multiple document types
  • Respond to queries
  • See where their submissions are in real time
  • Receive notifications and confirmation that required tasks are complete

Optimizing Assessments: Making Adjudicators and CEC More Efficient

  • Review dossiers
  • View medical images
  • Request additional information from CRO
  • Complete advanced eCRF and voting forms
  • Review individual adjudicator responses side-by-side
  • Complete CEC forms
  • Review workload and available cases

Reporting: Providing Sponsors and Data Managers with the Data They Need

  • Cross-protocol and cross-program reporting
  • Real-time dashboards
  • Multi-format data exports
  • User configurable dashboards
  • Standard reports
  • Adjudicator payment reports