Melbourne company Invision IT systems has developed its first piece of clinical trials software, which it says has a few advantages over the leading electronic data capture (EDC) vendors.

Invision released Evado last November 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, CEO Jennie Anderson said. 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 organisation (CRO) or external statistical consultants, Anderson said. The system's user interface is also "consistent across all forms" and profoundly simple to use trial-to-trial.

Medical device company Ventracor is now giving Evado a test run in a non-regulatory study of its implantable heart pump at two hospitals in Australia, she said. 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. 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 Heart Research Institute in Melbourne, where some clinical trial participants were getting "lost in the system" and leaving study visits prematurely, Anderson said. Evado's creators also consulted 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, Anderson said. 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, the Latrobe University Centre for Technology Infusion.

Evado's pre-clinical module is to be launched shortly with the intent 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, she said. 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. Demand for SaaS is coming from start-up companies in Australia and Southeast Asia.

A formal launch of Evado is being arranged by the Victorian Government on International Clinical Trials Day in May.