An established clinical products company in Melbourne, Australia, has developed its first piece of clinical trials software, which it says has a few advantages over the leading electronic data capture (EDC) vendors.
Last November, Evado was released by Invision IT Systems specifically to address the frustrations of researchers and the shortcomings of existing EDC systems. Evado is a “total management system” that does far more than capture data electronically, says CEO Jennie Anderson. It also has a repository for the uploading of images and other clinical documents, a built-in patient booking and tracking system, and can report on safety data in minutes.
Evado’s validation module, due for release at the end of April, will remove the need for statistical data validation by a clinical research organization (CRO) or external statistical consultants, Anderson adds. The system’s user interface is also “consistent across all forms” and profoundly simple to use trial-to-trial.
Impressed? So was global medical device company Ventracor, which is now giving Evado a test run in an important, non-regulatory study of its implantable heart pump at two hospitals in Australia, reports Anderson. A number of other customers are expected to be announced in coming months, including two that are running international trials.
Invision IT Systems previously developed healthcare and mobile applications, says Anderson. The Evado Clinical Trials Software Division was started four years ago with the start of Evado development. It has been designed in collaboration with universities, industry bodies, and CROs.
The idea for the booking and tracking system came from the Baker Research Institute in Melbourne, where some clinical trial participants were getting “lost in the system” and leaving study visits prematurely, says Anderson. Evado’s creators also listened to Monash University researchers who bemoaned the effort of manually collecting safety reporting data.
International CRO Kendle and local CROs Nucleus Network and Five Corners were helpful early on, providing Evado with assistance and valuable feedback, says Anderson. Motion Computing provided technical assistance and long-term loan of its tablet computers, including its newly designed C5 clinical tablet.
Invision IT Systems was the first Australian member of Microsoft’s BioIT Alliance that encourages collaborative innovation, says Anderson. Development of an installation wizard is under way with its newest partner, Latrobe University Centre for Technology Infusion.
In December, a third-party compliance audit revealed that Evado “exceeds requirements” of the U.S. FDA, says Anderson. February brings the release of Evado’s pre-clinical module, intended to ensure that collection of lab and animal data is in compliance with the FDA as well as TGA Australia. A number of Australian companies have been having problems with poor data collection, making it difficult to substantiate claims and move seamlessly into first-in-man trials. The unique module will include an electronic lab book and Wikipedia type functionality.
Evado is being offered initially as a Web-based application, but a software-as-a-service (SaaS) option will be available in March, says Anderson. Demand for SaaS is coming from start-up companies in Australia and nearby Southeast Asia.
A formal launch of Evado is being arranged by the Victorian Government on International Clinical Trials Day in May.
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