By Deb Borfitz
January 4, 2010 | After a “light release” in the fall of 2008, DecisionView finally has version 4 of its StudyOptimizer clinical trial software “market-ready”—this time, with a fourth top-ten biopharmaceutical company in the queue for the upgrade. The reward for the wait is a new foresight capability, allowing trial-sponsoring companies to leverage information about their completed trials to more accurately plan for their future patient recruitment efforts, says CEO Jim Scullion.
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| Jim Scullion |
The company’s flagship product now includes advanced historical analysis and templates capabilities, as well as more predictive analytics functionality, says Scullion. Coupled with StudyOptimizer’s existing features, including rear views of enrollment patterns and metrics plus real-time enrollment status of active trials, the application offers clinical trial managers a “comprehensive 360 degree view” of their organization’s patient recruitment performance.Scullion, who has successfully run several larger publicly-traded technology and enterprise software companies, replaced Steve Andrade as CEO of DecisionView in March 2009. The company subsequently stopped promoting the scaled-down version of StudyOptimizer 4 and began expanding its scope.
The latest release of StudyOptimizer 4 unleashes a bounty of information, including enrollment performance and study dropout rate, which companies could (but currently do not) use to craft site-of-choice arrangements, says Gonzalo Castro, vice president of products at DecisionView. Since the application now has the ability to export data and images to other systems, it might also prove useful in the areas of clinical trial supply, budgeting, and even protocol development.
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| Gonzalo Castro |
Of more immediate interest to sponsors is that StudyOptimizer 4 can draw on historical information from various “source systems,” notably electronic data capture and clinical trial management systems, to create templates pre-defining enrollment plans, says Scullion. More accurate planning and forecasting is enabled by tapping past experience with various studies, sites, and geographies.Version 4 can cope with some of the more complex variables that exist in trials of today, including enrollment starts and stops inherent to group sequential design, notes Castro. Later in 2010, DecisionView intends to unveil other software enhancements supportive of adaptive clinical trials. The company will also be optimizing cost forecasting for enrollment.
The user interface has been improved to include enhanced graphics and charts for easy viewing of enrollment performance across trials, sites, and countries, says Scullion. Knowing where actual performance exceeds or falls short of planned values allows trial sponsors to intelligently divvy up limited resources as well as quickly course-correct if anything goes awry.
The current installed base of StudyOptimizer users, including Wyeth Pharmaceuticals (now part of Pfizer) and GlaxoSmithKline (GSK), should all be utilizing version 4 by mid-year, says Scullion. GSK has credited StudyOptimizer with doubling the frequency with which it completes trials on time.
DecisionView routinely offers prospective customers a return-on-investment calculation based on its “parameters and data,” says Castro. The return is better for those opting for the newly available software-as-a-service version of StudyOptimizer that lowers the front-end cost of ownership. At the moment, one of the company’s four top-tier customers is accessing the application via cloud computing.
Extension of DecisionView’s optimization platform into clinical supply management and site selection are complimentary offerings the company plans to address in 2011, says Scullion. “This year, our entire focus will be on our clinical trial enrollment optimization solution.”