Case Study

Global biopharma sponsor selects dynamic innovation of Judi for Imaging on critical Phase 3 Oncology trial

Accurate Reporting

According to a paper authored by Dr. Scott Evans in the Journal of Experimental Stroke & Translational Medicine, missing data and miscommunication are two of the biggest threats to the integrity of a clinical trial. Dr. Evans writes, "Prevention is the first and most effective approach for addressing the missing data problem." Clinical studies require extensive data to flow between stakeholders, participants, and decision-makers. Challenges in trial design and cumbersome tools can introduce errors in the data flow, statistical noise in research, and suppress the speed and accuracy of decisions. This increases the cost and length of clinical trials and delays the delivery of vital new therapies that improve the lives of patients.

Enhanced Collaboration

Employing AG Mednet’s CORE principalsClient Centricity, Orchestrated Collaboration, Robust Simplicity, and Efficient and Secure Workflows, Judi helps clinical trial teams around the world come together to seamlessly manage complex interactions and insights, allowing them to do their best work, faster.

The Problem

A European-based multinational biopharmaceutical company working with a prominent imaging core lab required a unique solution for a complex clinical study testing the efficacy of a novel combination immunotherapy as a first-line treatment for patients with unresectable liver cancer. The success of the sponsor's trial could extend the lives of cancer patients worldwide. Globally, more than 800,000 people are diagnosed with liver cancer each year.

The Situation

The core lab and sponsor selected Judi for Imaging for its best-in-class de-identification of DICOM data; fast upload, retrieval, and secure storage of the trial's medical images, including MRI scans, CT scans, and source document PDFs—over 600 Patients, 170 Sites, and 4000 Endpoints. The sponsor also required a unique solution for better documenting treatment results scans at dynamic timepoints—serving a 9-week patient visit schedule until week 54, then possibly switch to a 6-week schedule at any point throughout the multi-year trial—depending on the clinician's diagnostic input. This variable was imperative for testing the success of the combined immunotherapy.

The Solution

Along with a fast and secure imaging workflow, the Judi Collaboration Platform is fully configured to the sponsor's clinical workflows, providing a dynamic and efficient way for clinical teams to manage, navigate, and analyze trial data. Flexing to the trial's needs, Judi automatically served a 6- or 9-week event schedule, activating after week 54, for all participants and sites, depending on the diagnostic input for each patient, paired with built-in real-time communication across multinational clinical teams. The easy-to-use Judi Collaboration Platform saved the sponsor significant time and expense by removing obstacles and the possibility of users introducing noise in the data because of cumbersome tools, navigation, or bloated design.

Tim Bove, Engineering Manager,
AG Mednet, Trial Delivery
"This complex study has variables that required flexibility and innovation to avoid the potential for user error. We created a dynamic solution that, to my knowledge, did not exist until now. No other platform could offer the clinical team the elasticity and ease like Judi by AG Mednet." 

About AG Mednet

AG Mednet is revolutionizing the clinical trial process through Judi, the innovative clinical trial collaboration platform. Designed to empower the ecosystems that drive clinical research, Judi streamlines workflows, facilitates communication, and accelerates the development of novel therapies for patients. The proven Judi platform is trusted by 19 of the top 20 global biopharmaceutical sponsors and 5 of the top 6 global CROs. Additionally, the Judi platform enables clinical teams worldwide to come together and seamlessly manage complex workflows in endpoint adjudication, eligibility, data safety monitoring, medical imaging, and other mission-critical areas of clinical development.

To learn more about Judi by AG Mednet, please contact the company at info@agmednet.com.

Case Study

Global biopharma sponsor selects dynamic innovation of Judi for Imaging on critical Phase 3 Oncology trial

Accurate Reporting

According to a paper authored by Dr. Scott Evans in the Journal of Experimental Stroke & Translational Medicine, missing data and miscommunication are two of the biggest threats to the integrity of a clinical trial. Dr. Evans writes, "Prevention is the first and most effective approach for addressing the missing data problem." Clinical studies require extensive data to flow between stakeholders, participants, and decision-makers. Challenges in trial design and cumbersome tools can introduce errors in the data flow, statistical noise in research, and suppress the speed and accuracy of decisions. This increases the cost and length of clinical trials and delays the delivery of vital new therapies that improve the lives of patients.

Enhanced Collaboration

Employing AG Mednet’s CORE principalsClient Centricity, Orchestrated Collaboration, Robust Simplicity, and Efficient and Secure Workflows, Judi helps clinical trial teams around the world come together to seamlessly manage complex interactions and insights, allowing them to do their best work, faster.

The Problem

A European-based multinational biopharmaceutical company working with a prominent imaging core lab required a unique solution for a complex clinical study testing the efficacy of a novel combination immunotherapy as a first-line treatment for patients with unresectable liver cancer. The success of the sponsor's trial could extend the lives of cancer patients worldwide. Globally, more than 800,000 people are diagnosed with liver cancer each year.

The Situation

The core lab and sponsor selected Judi for Imaging for its best-in-class de-identification of DICOM data; fast upload, retrieval, and secure storage of the trial's medical images, including MRI scans, CT scans, and source document PDFs—over 600 Patients, 170 Sites, and 4000 Endpoints. The sponsor also required a unique solution for better documenting treatment results scans at dynamic timepoints—serving a 9-week patient visit schedule until week 54, then possibly switch to a 6-week schedule at any point throughout the multi-year trial—depending on the clinician's diagnostic input. This variable was imperative for testing the success of the combined immunotherapy.

The Solution

Along with a fast and secure imaging workflow, the Judi Collaboration Platform is fully configured to the sponsor's clinical workflows, providing a dynamic and efficient way for clinical teams to manage, navigate, and analyze trial data. Flexing to the trial's needs, Judi automatically served a 6- or 9-week event schedule, activating after week 54, for all participants and sites, depending on the diagnostic input for each patient, paired with built-in real-time communication across multinational clinical teams. The easy-to-use Judi Collaboration Platform saved the sponsor significant time and expense by removing obstacles and the possibility of users introducing noise in the data because of cumbersome tools, navigation, or bloated design.

Tim Bove, Engineering Manager,
AG Mednet, Trial Delivery
"This complex study has variables that required flexibility and innovation to avoid the potential for user error. We created a dynamic solution that, to my knowledge, did not exist until now. No other platform could offer the clinical team the elasticity and ease like Judi by AG Mednet." 

About AG Mednet

AG Mednet is revolutionizing the clinical trial process through Judi, the innovative clinical trial collaboration platform. Designed to empower the ecosystems that drive clinical research, Judi streamlines workflows, facilitates communication, and accelerates the development of novel therapies for patients. The proven Judi platform is trusted by 19 of the top 20 global biopharmaceutical sponsors and 5 of the top 6 global CROs. Additionally, the Judi platform enables clinical teams worldwide to come together and seamlessly manage complex workflows in endpoint adjudication, eligibility, data safety monitoring, medical imaging, and other mission-critical areas of clinical development.

To learn more about Judi by AG Mednet, please contact the company at info@agmednet.com.

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

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Case Study

Adjudication

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Imaging

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Eligibility

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Monitoring

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DSMB

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Qualification

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Key Benefits for
Case Study
Trials

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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