Emissary Technology Key to Enrolling First Patient Within 7 Days of FDA Approval of a Dialysis Graft Trial
- Category: Emissary in the Clinical Research Press
Emissary Inc. has been selected by Novoste Corporation (Nasdaq:NOVT) to collaborate on monitoring and clinical trial management of Novoste's BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial.
The trial will utilize Emissary's proprietary TeamTrials(R) electronic data capture technology, which will increase the speed and efficiency of the clinical trial process.
BRAVO is the first multi-center clinical trial designed to investigate the use of catheter-based beta radiation in maintaining patency of vascular access grafts in patients undergoing long-term dialysis for end-stage renal disease. Approximately 230 patients will be enrolled at more than 20 centers in North America.
Novoste recently announced the enrollment of the first patient in the trial at the University of Cincinnati. This event occurred just seven days after receiving FDA approval for the trial. "Emissary's extensive experience in the medical device arena and their commitment and dedication to our company have been key factors in the rapid launch of this important trial," said Pia Mikkelsen Lynch, MD, VP, Global Clinical Affairs of Novoste Corporation. "Additionally, we are excited about the potential savings in time and cost from the use of Emissary's TeamTrials technology."
TeamTrials is a clinical research software platform developed by Emissary that allows the collection of clinical data and the monitoring of clinical trials via the Internet. "BRAVO is the ideal study to showcase the ability of TeamTrials to create a unified team out of the many clinical researchers spread across multiple hospital departments, dialysis clinics and research facilities throughout the U.S.," said Steven W. Mayo, PD., Chairman and CEO of Emissary.
About Emissary Inc.
Emissary Inc. based in Austin, Texas, is a privately-held contract research organization (CRO) with operations in Canada and Europe as well. Established in 1995, Emissary is comprised of experienced, therapeutically-oriented teams of clinical research professionals with a commitment to rapidly bringing life-saving and life-improving medical products to market. This passion has led to the development of TeamTrials, an expansive software platform designed to reduce the cost, time and complexity of clinical trials through the establishment of a worldwide clinical research community of patients, investigators and clinical researchers. Using advanced e-pharma technologies such as electronic data capture (EDC), electronic document management, online patient recruitment and collaborative workflow, TeamTrials finally brings together all the various participants in a clinical trial.
Emissary(R) and TeamTrials(R) are registered trademarks of Emissary Inc.