Aneurysm Research at University of Maryland Supported by OpenClinica EDC Platform
The University of Maryland School of Medicine uses OpenClinica's EDC platform to support their multi-center aneurysm trial.
OpenClinica, LLC announces that University of Maryland School of Medicine has selected the OpenClinica Enterprise Edition for the Ultra Registry, a multi-center aneurysm trial led by Dr. Gaurav Jindal, Professor of Diagnostic Radiology. The radiology department at the University of Maryland has state-of-the-art facilities and cutting-edge technologies, making it one of the most sophisticated in the world. The development and integration of nuclear medicine, ultrasonography, computed tomography and magnetic resonance imaging (MRI) has provided diagnostic imaging with an even more central role in diagnosis and selected (interventional) therapeutic procedures.
Gabrielle Messina, data manager and clinical research specialist for the Ultra Registry, chose OpenClinica based on the open architecture and the ability to receive professional training, not only on the OpenClinica system but on best practices in executing a clinical trial with an EDC system. “I took OpenClinica’s training in February of this year and the staff was committed to ensuring my success. I needed extra guidance, specific to my study, and the knowledgeable client services team took the time, outside of class, to make sure I understood how to build and validate my CRFs. The commitment and professionalism of the OpenClinica team was outstanding and confirmed not only the great value of this EDC system, but has given me peace of mind with my capacity to execute my trial,” said Gabrielle.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
