Critical Importance

According to research by Brennan C. Kahan, Brian Feagan, and Vipul Jairath published in Springer's Trials, the authors state, "Outcome adjudication is of critical importance to ensure validity of trial results, although no one approach is optimal across all settings. Investigators should choose the best strategy based on the specific characteristics of their trial." However, the research underscores that incorrect classification of outcomes in clinical trials can lead to biased estimates of treatment results and reduce the power and viability of research. Life Sciences processes require extensive data to flow between stakeholders, participants, and decision-makers. Cumbersome processes, and a lack of transparency in the data flow, introduce errors, and inhibits the speed and accuracy of decision-making. This increases the cost and length of clinical trials and delays the delivery of vital therapies that improve the lives of patients.

Enhanced Collaboration

Employing AG Mednet’s CORE principals—Client 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 multinational biopharma company working with a major CRO required a unique solution for a clinical program with multiple trials to test the safety and efficacy of a new biologic treatment of three related, yet distinct, chronic respiratory diseases—including severe asthma—in patients dependent on corticosteroids. In 2019, Global Burden of Disease researchers estimated over 260 million people globally had poorly controlled asthma. Long-term steroid use and dependency are correlated with adverse effects including heart problems, psychiatric disorders, and increased mortality. The success of the sponsor's trial will reduce or remove dependence on steroid medications and provide a significant improvement in quality of life for hundreds of millions of people, decrease hospitalization, and lower healthcare cost by billions in all countries.

The Situation

The CRO and trial sponsor selected Judi for Adjudication for its best-in-class adjudication of clinical endpoint data, event tracking, query generation, document collection and de-identification of DICOM data; and organized reporting—over 900 Subjects, 150 Endpoints, 200 Sites. The sponsor also required a unique workflow for the primary adjudicator’s assessments of three key event types that would allow the Committee Chair to review and submit findings more quickly and remove the risk of manual entry error.

‍The Solution

Along with a fast and secure adjudication workflow, the Judi Collaboration Platform is fully configured to the sponsor's requirements, allowing investigators to "choose the best strategy," 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 Chair Review Form with the adjudicators’ answers pre-populated, so the Chair only need agree or disagree with the assessment. The easy-to-use Judi Collaboration Platform saved the sponsor time and expense by removing obstacles, and eliminating the risk of users introducing incorrect classification of outcomes because of cumbersome workflows, navigation, or inefficient design.

"These complex and concurrent global clinical trials have specific requirements that commanded an innovative solution that only the Judi platform can provide. Judi by AG Mednet proactively removed the potential for errors that would compromise data results." 

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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.