Inspection Readiness: European biopharma and partner CRO employ dynamic controls of Judi for Adjudication and Site & User Qualification
Best Clinical Practices
Both 21 CFR Part 11 and GCP require the maintenance of accurate and complete records. Training users in these regulations helps maintain audit readiness. If users are qualified and trained to handle electronic records and systems in accordance with regulatory standards, audits are more likely to go smoothly, and the organization can avoid costly findings and penalties.
While compliance with regulations is a priority, the efficient operation of clinical trials is equally important. Properly trained and qualified users are more likely to work efficiently within the framework of GCP and 21 CFR Part 11, avoiding unnecessary delays and errors that can affect trial timelines and budgets.
The Problem
A European-based biopharma company required a unique solution for a global clinical study to test the safety and efficacy of a novel immunotherapy designed to treat Systemic Lupus Erythematosus (SLE). More than five million people have some form of Lupus. This incurable autoimmune disease can cause complications that lead to premature death. The success of the sponsor's trial will provide a new treatment for patients with SLE worldwide. The CRO and biopharma also required an integrated solution to centrally manage and monitor clinical site qualification and global user training.
The Situation
The CRO and trial sponsor selected Judi for Adjudication for its best-in-class adjudication of clinical endpoint data, query generation, document collection, event tracking, and de-identification of DICOM data; and organized reporting—over 250 Endpoints, Multiple Sites.
The sponsor and CRO added Judi for Site & User Qualification to centrally manage global site and user qualification processes, including training, data collection, and reporting, ensuring every step is followed by every site and user—as the trial needed a solution that could manage qualification and adjudication processes within an integrated platform.
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.
Along with a fast and secure adjudication workflow, the Judi Collaboration Platform provided an efficient way for the biopharma sponsor to remotely manage site and user qualification through role-based training and certification within Judi for the global trial. Moreover, before the trial was live, the sponsor and CRO requested additional ad-hoc interactive training exams for end users. Because the Judi Collaboration Platform is fully configured to meet the needs of the sponsor's workflows, the training review was adjusted and deployed without delay to the trial conduct. Judi saved the sponsor significant time and served as a regulatory safeguard to ensure only qualified users had the ability to operate within the platform—ultimately ensuring the trial integrity would never be jeopardized.
"The CRO and sponsor required the ability to qualify site users, and implement, manage, and store user training and compliance records, while also powering the adjudication of a global rare disease trial where patient retention is mission-critical…all within the same platform. To my knowledge, these capabilities didn't exist together before Judi. No platform could offer a truly unified solution like Judi."
–Jennifer Wiley, Senior Project Manager, AG Mednet
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.
