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New portable eClinical suite Timaeus HotSpot allows for quicker and more secure data transfer.
In late March, the office of Senator Sherrod Brown (D-OH) sponsored a panel discussion and exhibit at Washington, DC's US Capitol Visitors Center to bring attention to the global tuberculosis (TB) epidemic and feature work under way to combat the disease. One eClinical technology provider had the opportunity to highlight how the Apple iPad is changing the future of global trials, even in emerging regions where technology has not been widely used in clinical trials.
Tablet technology is a versatile tool for vendors, CROs, sponsors, investigators, and monitors
James Haughwout, Vice President of Commercialization and Operations at Cmed Technology (Horsham, UK), spoke to Applied Clinical Trials about World Tuberculosis Day activities in Washington, as well as the Wi-Fi or "hot-spot" technology integrated into its Timaeus on-demand eClinical platform late last year.
At the event, "Overcoming Obstacles to Achieve Results: Tuberculosis in the 21st Century," organizers invited Cmed Technology to demonstrate the way innovation in technology is being used by Aeras, a non-profit product development organization dedicated to the development of new TB vaccines. Aeras collaborates with numerous academic and research institutions in Africa and Asia to conduct clinical research. In 2008, Aeras began using Timaeus Mobile, a laptop appliance that travels wherever study teams go to perform data capture and data management using mobile phone data cards in a large-scale clinical trial.
Other exhibitors included a Gene-Xpert diagnostic test, equipment used in smear microscopy, and information about promising TB drug regimens. According to Haughwout, about half of the 100 attendees were on the treatment and care side, and the other research and development. "What surprised me was the questions I received," said Haughwout. "Rather than getting 'oh neat, an iPad' the questions were very eClinical based. For example, 'If we are collecting data in Africa, can we check for errors as soon as it is entered?' or 'Can we [researchers and regulators] see an audit trail [of the data]?' There was an understanding of how the physicians work in trials as well as knowledge of the regulatory issues involved in data collection in clinical trials."
According to Haughwout, Timaeus HotSpot was previewed late last year and is the industry's first portable eClinical suite that uses a variety of Wi-Fi mobile devices, such as the iPad. "Timaeus HotSpot has been engineered the same way smartphones work. If you get on an airplane, you can write e-mails on your BlackBerry. When you get off the plane, it detects the network is present, and it synchronizes the data back to the server at your office. Timaeus HotSpot is built the same way for clinical data," he said.
One of the main security benefits of Timaeus HotSpot is that the iPad itself does not hold the data. The data is stored and encrypted in the Timaeus HotSpot hub, which can be an on-site dedicated PC, laptop, or mini-tower and accessed from Wi-Fi devices like the iPad. The hub transmits the encrypted data in real time to the sponsor. However, were the iPad to be lost or stolen, there would be no security breach. And the iPad itself offers location technology for recovery through Apple.
Haughwout maintains that Apple has developed a tablet that consumers really want to use because it is intuitive and user-friendly. It also translates especially well to the eClinical world. "The pinch-zoom-swipe of the iPad is paper-like in the experience. With a keyboard, doctors still need to turn to the keyboard to input, but the iPad works right there in front of a patient. It's a nicer interface to walk around with," he added. By offering both the mobile and touchscreen technology of the iPad, vendors, CROs, and sponsors can now allow investigators, monitors, and others the ability to work in the medium they like best.
According to Haughwout, many current iPad applications in the clinical trials space are dependent on the effect and speed of 3G. Timaeus HotSpot eliminates this issue and is therefore faster.
Cmed will be demoing its Timaeus HotSpot at the annual DIA meeting next month in Chicago.