Rare Disease

Advancing rare disease therapies requires a rare partnership.

In Rare Disease trials, every second matters and every patient enrolled is critical. The standard of care and inclusion and exclusion criteria are often highly specific and can make it difficult to find, recruit, and enroll patients quickly, potentially delaying trial milestones and outcomes. Single patient sites may be geographically dispersed, making on-site monitoring problematic. We understand the nuances and special circumstances of rare disease clinical development—and we’re here to help.

Solving the Unique Needs of Rare Disease Trials with Judi

Judi for Eligibility: Precision in Patient Eligibility Determination

Rare Disease trials often face the challenge of identifying and enrolling the right patients from a small and widely dispersed population.Judi for Eligibility streamlines this process by providing a robust framework for centralized screening committees to review and approve patient eligibility.This ensures that your trial enrolls participants who meet the specific, often stringent, inclusion and exclusion criteria necessary for meaningful results.With Judi, you can efficiently manage the delicate balance between patient recruitment and maintaining the integrity of your trial’s outcomes.

Judi for Monitoring: Scalable Remote Monitoring Solutions

Judi for Monitoring offers a scalable and flexible approach, tailored to the specific needs of your Rare Disease trial. Whether managing a small, single-site study or a large, multi-center trial, Judi adapts to your remote monitoring strategy. This flexibility is essential for Rare Disease trials, where the diversity of trial sites and the variability in patient enrollment necessitate a monitoring strategy that can scale with the trial’s demands.

Judi for Imaging: Managing Complex Data in Specialized Therapeutic Areas

In Rare Disease trials, imaging data often plays a critical role in assessing disease progression and treatment efficacy. Whether dealing with rare genetic disorders or orphan diseases requiring specialized imaging techniques, Judi for Imaging provides a secure, centralized platform for managing these complex datasets. The platform ensures that imaging data is accurately collected, stored, and reviewed, minimizing the risk of data discrepancies and enabling timely, informed decision-making. Judi’s ability to handle intricate imaging workflows is crucial in trials where every data point can significantly impact the outcome.

Judi for Adjudication: Ensuring Adherence to Novel Endpoint Assessment

Endpoint adjudication in Rare Disease trials is particularly challenging due to the specialized nature of the diseases and the need for consistent, unbiased evaluation of clinical events. Judi for Adjudication offers a completely configurable, secure platform that facilitates the centralized adjudication process in line with your standard operating procedures and processes, allowing for the accurate and consistent assessment of endpoints.This is especially important in Rare Disease trials, where the rarity and variability of clinical events require meticulous adjudication to ensure the validity of the trial results.

Driving Success in Rare Disease Research

In Rare Disease trials, the stakes are high, and the challenges are many. Judi’s integrated platform is designed to help you overcome these challenges, offering solutions that enhance data security, streamline complex workflows, and ensure compliance with global regulatory standards. Whether you’re managing imaging data, patient eligibility, or endpoint adjudication, Judi provides the tools you need to deliver reliable, meaningful results—helping to bring life-changing therapies to those who need them most.

Elevate Your Rare Disease Trials with Judi

Request a demo today and discover how Judi can transform the way you advance Rare Disease programs.

Rare Disease

Advancing rare disease therapies requires a rare partnership.

In Rare Disease trials, every second matters and every patient enrolled is critical. The standard of care and inclusion and exclusion criteria are often highly specific and can make it difficult to find, recruit, and enroll patients quickly, potentially delaying trial milestones and outcomes. Single patient sites may be geographically dispersed, making on-site monitoring problematic. We understand the nuances and special circumstances of rare disease clinical development—and we’re here to help.

Solving the Unique Needs of Rare Disease Trials with Judi

Judi for Eligibility: Precision in Patient Eligibility Determination

Rare Disease trials often face the challenge of identifying and enrolling the right patients from a small and widely dispersed population.Judi for Eligibility streamlines this process by providing a robust framework for centralized screening committees to review and approve patient eligibility.This ensures that your trial enrolls participants who meet the specific, often stringent, inclusion and exclusion criteria necessary for meaningful results.With Judi, you can efficiently manage the delicate balance between patient recruitment and maintaining the integrity of your trial’s outcomes.

Judi for Monitoring: Scalable Remote Monitoring Solutions

Judi for Monitoring offers a scalable and flexible approach, tailored to the specific needs of your Rare Disease trial. Whether managing a small, single-site study or a large, multi-center trial, Judi adapts to your remote monitoring strategy. This flexibility is essential for Rare Disease trials, where the diversity of trial sites and the variability in patient enrollment necessitate a monitoring strategy that can scale with the trial’s demands.

Judi for Imaging: Managing Complex Data in Specialized Therapeutic Areas

In Rare Disease trials, imaging data often plays a critical role in assessing disease progression and treatment efficacy. Whether dealing with rare genetic disorders or orphan diseases requiring specialized imaging techniques, Judi for Imaging provides a secure, centralized platform for managing these complex datasets. The platform ensures that imaging data is accurately collected, stored, and reviewed, minimizing the risk of data discrepancies and enabling timely, informed decision-making. Judi’s ability to handle intricate imaging workflows is crucial in trials where every data point can significantly impact the outcome.

Judi for Adjudication: Ensuring Adherence to Novel Endpoint Assessment

Endpoint adjudication in Rare Disease trials is particularly challenging due to the specialized nature of the diseases and the need for consistent, unbiased evaluation of clinical events. Judi for Adjudication offers a completely configurable, secure platform that facilitates the centralized adjudication process in line with your standard operating procedures and processes, allowing for the accurate and consistent assessment of endpoints.This is especially important in Rare Disease trials, where the rarity and variability of clinical events require meticulous adjudication to ensure the validity of the trial results.

Driving Success in Rare Disease Research

In Rare Disease trials, the stakes are high, and the challenges are many. Judi’s integrated platform is designed to help you overcome these challenges, offering solutions that enhance data security, streamline complex workflows, and ensure compliance with global regulatory standards. Whether you’re managing imaging data, patient eligibility, or endpoint adjudication, Judi provides the tools you need to deliver reliable, meaningful results—helping to bring life-changing therapies to those who need them most.

Elevate Your Rare Disease Trials with Judi

Request a demo today and discover how Judi can transform the way you advance Rare Disease programs.

Oncology
Partnership Success Story

Prominent clinical-stage biotech combines Judi for Eligibility and Judi for Adjudication on pivotal Phase 2 CAR-T oncology trial with over 600 endpoints

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Rare Disease
Partnership Success Story

International biopharma sponsor and partner CRO maximize flexibility of Judi for DSMB for Phase 2 multinational clinical program with over 100 patients and 60 sites

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Oncology
Partnership Success Story

US-based biopharma leverages scalability of Judi for Imaging on three concurrent pulmonary oncology trials

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Rare Disease
Designed for predictability in rare journeys

Adjudication

Connect all of your stakeholders with instant access to the data and information needed to expedite and improve the clinical event and endpoint determination processes.
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Imaging

Process medical images through flexible workflows including evaluation, eCRF creation, AI-Assisted PHI redaction, and reporting.
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Eligibility

Automates the central patient eligibility review process to quickly achieve final determination and advance your randomization targets.
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Monitoring

The complete solution to executing a remote monitoring strategy.
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DSMB

Provides a consistent approach to data safety monitoring board / data monitoring committee meeting management, complete with regulatory-compliant full audit trail.
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Qualification

Maintains compliance and administrative oversight into critical clinical system user access management.
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Key Benefits for
Rare Disease
Trials

Navigating rare disease clinical trials requires innovative strategies to overcome challenges.

Experience

For over 15 years, Judi by AG Mednet has partnered with most of the world’s biopharmaceutical and medical device trial sponsors to advance and improve patient outcomes through successful clinical development.

Unmatched Flexibility

Unlike legacy "platform" providers, Judi was designed from the ground-up to solve for the dynamic variability of clinical conduct and process required in rare disease programs. Judi is always configured to adapt to your process—not ours.

Security and Compliance

Secure, compliant data management and audit trails provide the confidence of today’s regulatory environment. Judi is HIPAA, GDPR, SOC-2, and 21 CFR Part 11 compliant.

Partnering for Success

Leveraging the power and flexibility of Judi’s solutions has become a standard at most major biopharmaceutical and CRO entities. No matter the size, phase, or complexity of the clinical project or program, working with AG Mednet means you’ll have more than a technology partner, you’ll have an ally that values the nuances of your work as much as you do.

Key Features

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

Specific roles or groups to chat about a case or a project, 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. 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

Stay up-to-date with whats happening

Some sub copy covering what weekly/monthly update sand news one can expect.

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

Specific roles or groups to chat about a case or a project, 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. 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

See Judi in Action; Request a Demo today

Contact us today to learn more about how Judi can automate, expedite, and improve your clinical trials.

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