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"Direct data entry onto mobile devices which then synchronize directly with our back end database has virtually eliminated missing data and dramatically improved the accuracy of the data collected."

Peter O'Blenis
VP Marketing

TrialStat is an Ottawa, Canada based technology and services company providing powerful, highly cost-effective, turnkey data capture and management tools for healthcare researchers. In order to mobilize an existing web-based data collection and management solution for clinical research and enable disconnected use by researchers TrialStat developed an extension of its ClinicalAnalytics solution based on M-Business Anywhere and SQL Anywhere.  The solution enables the use of mobile devices with or without an Internet connection while employing the same data collection forms used in the Web-based version.

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Efficient, Flexible and Secure
Capturing and managing data is a mission-critical process for many organizations. When the organization's mission, however, is clinical research related to pharmaceutical trials and other healthcare investigations, it is particularly important that the data management solution be accurate, efficient, flexible and secure.

It was for these reasons that when TrialStat, an organization focused exclusively on providing data management solutions for clinical research, needed to extend its highly regarded ClinicalAnalytics data management platform to mobile users, it turned to iAnywhere. 

"TrialStat is an electronic data management company that works in the clinical research field primarily with contract research organizations, biotech companies, small- to mid-sized pharmaceutical companies, and some government and government funded institutions," explains Peter O'Blenis, TrialStat's Vice President of Marketing. "There are two major areas in which we help these organizations conduct their research. The first is in the design of the numerous forms and permissions they need to use to collect their data. That's the configuration phase. Then there's the actual data collection and management that is the heart of the research process and which is necessary to allow them to analyze and report on their work."

There was a time, not so long ago, when these processes were paper-based. Managing paper, however, is cumbersome, error prone and inflexible when the need arises to update a form due to a change in a research protocol, for example. Government regulations also mandate that research documentation must be retained for auditing purposes for years after the completion of a study, which creates additional challenges and burdens for research organizations using paper-based methodologies.
TrialStat created its ClinicalAnalytics data management solution to improve upon the old paper-based methods.

Hosted Solution Supports Disconnected Mobile Workers
Designed as a Web-based solution, ClinicalAnalytics allows researchers to configure and deploy their studies rapidly and without the assistance of programmers; to improve the quality and accuracy of the data collected; to quickly and easily make mid-study changes to protocols, forms, sites and investigators; and to examine data at any time throughout the course of a study. By eliminating paper and the need to key results into systems as data is collected, ClinicalAnalytics also reduces study costs.

"We provide ClinicalAnalytics as a hosted solution," says Khaled El Emam, TrialStat's Chief Technology Officer. "It's 100 percent user self-service, which is unique in our industry and a key to its success."

As it was originally designed, however, ClinicalAnalytics required users to be connected to the Internet to enter and access data. The problem was that many studies involved researchers, nurses and other field workers meeting with study subjects and collecting data in environments in which they had no Internet connectivity. It might be a nurse at a subject's home or a clinician working in a medical records library in the basement of a hospital where even a wireless connection was unavailable.

El Emam explains, "Researchers need access to their forms and data 24/7, wherever they happen to be. What happens when you can't get an Internet connection or your network is down? Either your study stops, or you begin copying information onto paper, which then obligates you to hang onto that paper until long after that study has been completed. If you don't have the ability to continue working disconnected, you find yourself back in the business of managing paper again. We knew we had to provide that disconnected capability."

M-Business Anywhere and SQL Anywhere Meet TrialStat's Exacting Criteria
TrialStat researched a number of potential solutions that would enable it to provide this capability based on a list of criteria it developed. "We needed a solution that provided cross-platform support for Pocket PC and Palm devices," says El Emam. "It had to have a local database that would run on the devices and that we could encrypt and lock down and a synchronization capability that would also secure the data in transit as it moved between the devices and our consolidated SQL Server database. Finally, it had to be something that we could integrate into our own solution suite. So the licensing model had to allow us to deploy it as a service. Given those criteria and the solutions we researched, we chose iAnywhere's M-Business Anywhere Web content and application delivery platform and SQL Anywhere's UltraLite database."

TrialStat found the iAnywhere technology to be both versatile and powerful in terms of its ability to render existing Web-based forms for mobile devices and to allow users to continue collecting data in the absence of a connection to the Web.

The TrialStat platform allows project designers with no technical software skills to create data collection forms, design rules and workflow and to script logic and validation requirements using browser-based wizards. The platform then utilizes iAnywhere technology to deploy these forms and logic to selected mobile and disconnected devices with a single click.

"That is really one of the biggest advantages we found in the iAnywhere technology," says El Emam. "You can deploy essentially the same code on the Web and on the mobile devices because it's JavaScript on both. You just go onto the Web, design everything, click, hot sync, and everything goes to the mobile device so users can begin entering data. And if you need to make changes to the online forms on the Web, when the mobile user synchronizes, those changes are automatically sent down to the mobile device."

"Certain Studies Could Not be Done Without Our Mobile Solution"
With as many as 60 studies typically running at any given time, TrialStat has had ample opportunity to judge the performance of its M-Business Anywhere-enabled mobile solution.
"We've seen the time and effort required to deploy a study reduced dramatically thanks to our mobile solution," O'Blenis reports. "A typical study in this industry can cost hundreds of thousands of dollars just for the data capture piece and we've seen examples in which our platform, utilizing the M-Business Anywhere technology, has reduced that cost by as much as 60 percent. Also, the ability to make changes to forms quickly and without any professional services costs has saved our clients thousands of dollars in custom programming that would otherwise be required. More importantly, perhaps, certain studies simply could not be done without our mobile solution. The only alternative would be paper which really negates many of the benefits of EDC. Direct data entry onto mobile devices which then synchronize directly with out back end database has virtually eliminated missing data and dramatically improved the accuracy of the data collected."

"We're very happy with our decision to work with iAnywhere," El Emam adds. "The technology and the assistance we've received from iAnywhere's Professional Services team have enabled us to do things that would otherwise have been much more difficult and expensive given our business requirements.

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