Mobilising data capture

Despite remarkable advances in drug and medical device development, much of the work behind the scenes in the clinical trial sector is still based on antiquated, expensive and slow paper-based collation of data.

The average trial will cost hundreds of millions of dollars and require detailed and complex co-ordination of patients, physicians and regulatory agencies around the world over a period of several years.

One way to speed up clinical trials is to use smart devices, particularly for electronic data capture. Australian software developer Evado has devised its own form of clinical trial software, a web-based mobile electronic trial data collection system.

One of its first users is medical device company Ventracor, which is using Evado in its research project to design an optimal way of automatically and safely changing the speed of its left ventricular device, VentrAssist.

“Huge savings in time and money can be made in the electronic collection of clinical data,” EVADO CEO Jennie Anderson says.

“Information can be accurately passed from the mobile collection device to the web without having to be faxed, posted or couriered or re-keyed.”

Anderson says the uptake of electronic data capture by one of the most forward-looking industries has been slow because many portable digital organisers and mobile phone applications require users to toggle up and down a screen to capture data.

“This makes accurate data collection difficult for the busy and technology-challenged researcher, who often has multiple priorities and is working on the trial as an addition to their normal work load,” she says.

Screen size is another issue. Small screens are hard to read and data can be difficult to enter and manipulate. A number of these solutions have been implemented but not had wide support and a large number have then been discarded because they were not user friendly. Evado’s software comes in two versions: Pre Clinical, for animal and first human trials, and Clinical, for Phase I to IV, and meets all FDA requirements.

It was developed in association with La Trobe University software researchers and the facilities at its Microsoft Centre, along with global computer chip maker Intel, which has created the mobile data assistant with Motion Computing, a tablet computer manufacturer for acute health and clinical applications like Evado.

“You can write on the screen of this disinfectable tablet computer and use it in any environment,” Anderson says. “It can also be used to take photographs, scan bar codes and it has an RFID reader and is Bluetooth enabled.

“The take-up of these devices in the US has been very strong and Australia and Asia are now following America’s lead.”

Evado has mapped the workflow of clinical trial researchers, so users can download the data they need for the day or week, maximising privacy functionality. Anderson says has been designed so that researchers can collect data on larger screens in format that is very similar to a paper based clinical research forms. It also works on and off line.

“For research based trials you often want to make changes and the nice thing about Evado is that you can make those changes and you can customise it for your own purposes,” Ventracor’s John Woodard says.

“It’s very flexible and it’s inexpensive in comparison to lots of other databases. We’re very pleased with it.”