European-based pharma and major CRO utilize dexterity of Judi for Eligibility on pivotal phase 3, novel psychedelic clinical program
Quickly Correct Inefficiencies
In a recent study published in Clinical and Experimental Medicine, the authors state the success of clinical trials depends on correct eligibility criteria. Inappropriate criteria together with cumbersome processes cause insufficient recruitment, which is a reason for the collapse of many clinical trials. Life Sciences processes require extensive data to flow between stakeholders, participants, and decision-makers. A lack of transparency in the data flow and an inability to quickly address inefficiencies inhibits the speed of decision-making. This increases the duration and cost 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 European-based pharmaceutical company required an agile and secure solution for a global clinical program to test the efficacy, safety, and tolerability of a breakthrough psychedelic therapy designed to improve the lives of people with Treatment-Resistant Depression (TRD). Depression is the leading cause of disability worldwide, and approximately one-third of people with Major Depressive Disorder have TRD, with residual depressive symptoms that increase impairment, mortality, and risk of suicide. A study published in 2021 in the Journal of Clinical Psychiatry estimated that in the United States the annual financial burden of Treatment-Resistant Depression is $43.8 billion. The success of the sponsor's trial will provide a new alternative to effectively manage TRD, with broad societal gains. Treatment-Resistant Depression affects an estimated 100 million people globally.
The Situation
The trial sponsor and CRO agreed to select Judi for Eligibility for its 100% configurable workflow; best-in-class de-identification of DICOM data; dashboards, reporting, real-time communication; and ability to facilitate a patient screening process with complex criteria of eligibility review, combined with custom, instant progress notifications for the international clinical team overseeing 1000 Patients at over 25 Sites.
The Solution
Along with a nimble and secure eligibility workflow, the Judi platform provided an efficient way for the sponsor and CRO to manage its complex patient screening eligibility review. Furthermore, after the trial was live, the sponsor discovered clinicians needed an additional eligibility criteria determination that triggers unique real-time notifications to specific members of its clinical team, without delaying the trial. Because the Judi Collaboration Platform is fully configured to meet the needs of the sponsor's workflows, the live trial was adjusted with zero delay, adding the new criteria, without losing patient eligibility or adding months to the program. The purpose-built Judi Collaboration Platform saved the sponsor significant time and expense, and loss of vital patient data.
AG Mednet, Trial Delivery
"This pivotal psychedelic study had unique parameters, and multiple sites in over a dozen countries, requiring a streamlined and precise criteria review process. Only the Judi platform can offer the study sponsor and CRO the right solution in the right time frame."
About AG Mednet
AG Mednet is revolutionizing the clinical trial process through Judi, the innovative and award-winning 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.
