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 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 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.
"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.