Prominent medical device company leverages the flexibility of Judi for Imaging and Eligibility on pivotal phase 3 medical implant trial
Speed of Decision-Making
The National Institutes of Health states more than 50 percent of clinical studies cannot retain necessary research participants, which can increase health disparities and slow the pace of progress. 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 United States-based medical device company required a unique solution for a global clinical study to test the safety and efficacy of a novel device designed to treat Lower Urinary Tract Symptoms in patients with Benign Prostatic Hyperplasia (BPH). The success of the sponsor's trial will provide a minimally invasive alternative to major surgery and medication for men worldwide—BPH is a health concern in all countries.
The Situation
The medical device sponsor selected Judi for Imaging for its best-in-class de-identification of DICOM data; fast upload, retrieval, and secure storage of an array of its trial's medical images, including CT scans, source document PDFs, and cystoscopy videos—240 Subjects, 960 Endpoints, Multiple Sites. The sponsor added Judi for Eligibility for its 100% configurable workflow—as the trial needed a system that could facilitate a patient screening eligibility process with 2-3 stages of eligibility review.
The Solution
Along with a fast and secure imaging workflow, the Judi Collaboration Platform provided an efficient way for the medical device sponsor to manage its multi-stage patient screening eligibility review. Moreover, after the trial was live, the sponsor realized sites were recording necessary patient data, such as CT scans and cystoscopy videos, at a disparate pace and needed to re-configure its review process to better determine patient eligibility, and more quickly. Because the Judi Collaboration Platform is fully configured to meet the needs of the sponsor's workflows, the live trial was adjusted without losing patient eligibility or adding months to the trial. The purpose-built Judi Collaboration Platform saved the sponsor significant time and expense, and loss of vital patient data.
AG Mednet, Trial Delivery
"In my tenure at AG Mednet, I’ve helped many clients with Eligibility and Imaging trials, yet this pivotal medical device study has the most unique requirements I’ve encountered, and demanded an innovative solution. No other platform could offer the sponsor a fully-configured solution 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.
