Duke University medical center has licensed Alphadas electronic data capture (EDC) software to accelerate and streamline clinical trials and to enable physicians to follow patients more closely
Researchers at Duke, which will become the first academic medical centre in the USA to use the Alphadas system, believe the technology has the potential to be a more accurate, real-time system that may improve the safety of clinical trial participants and contribute to more timely development of new drugs.
The agreement was announced today at the 44th annual Drug Information Association meeting in Boston.
"We will be using this innovative system in our two clinical research units as well as in our new, 30-bed Phase I Duke Clinical Research Unit (DCRU)," said Robert Califf, MD, director of the Duke Translational Medicine Institute and vice chancellor for clinical research at the Duke University School of Medicine.
"The Phase I trial programme here will become the hub of our efforts in translational science.
"It's where we will do some of our most exciting work, which will focus on proof-of-concept studies evaluating the impact of new therapies on human systems biology".
Duke will pay for the project through support from the Clinical and Translational Science Award, a five-year, $53 million grant from the US National Institutes of Health awarded to Duke in 2006.
The grant is intended to transform how clinical and translational research is conducted, and enabling researchers to develop new treatments faster and deliver them to patients more efficiently and quickly.
Barry Mangum, director of clinical pharmacology for the DCRU and associate clinical professor of clinical pharmacology at Duke University Medical Center, says the proprietary Alphadas software will run on the DCRU's computer system to capture, integrate and report on clinical data in real-time.
"In using this system, we will be able to capture and enter specific patient-safety data necessary for accurate adverse-event reporting, while also collecting other key data components that will aid us in designing a dose and dosing interval for that specific subject population," he said.
Logos Technologies has been providing early phase EDC and clinical site automation tools to the pharmaceutical industry for over ten years.
"We look forward to this opportunity to work with Duke, a leading and world class academic medical center," said Giles Wilson, co-founder of Logos Technologies.
"The partnership will help us achieve our mission to reduce the development time of life-saving and life-enhancing drugs.
"We very much look forward to working with Logos Technologies to implement Alphadas at Duke" said Steve Woody, associate CIO for translational and clinical research for Duke Medicine.
"We evaluated the market and believe Alphadas to be the best fit for our needs in developing a first-class proof-of-concept global effort."
