By Deb Borfitz
November 16, 2009 | With the latest update to its web-based clinical trial software, ClearTrial has integrated study planning with project and financial tracking to help life science companies better visualize where they can reduce costs and add velocity to the trial process without sacrificing accuracy and quality of results. ClearTrial Track, the latest addition to the software suite, makes ClearTrial v3.0 the only system in the industry enabling fast and accurate project tracking, management of accrued liabilities, and re-forecasting for change orders and midstream study adjustments, says CEO Mike Soenen.
For the folks in clinical R&D finance, in particular, this is the Holy Grail of resource planning and study management. “Everyone tracks like crazy in this industry, but still don’t know where they’re supposed to be…or where they’re headed,” says Soenen. Clinical trial management systems, focusing as they do on clinical activities rather than clinical operations and forecasting, can offer limited guidance. ClearTrial accomplishes those tracking and forecasting tasks quickly and easily, requiring no accounting know-how on the part of users.
ClearTrial Track is part of the company’s ongoing response to the “overarching need to be more efficient and cost sensitive in the whole R&D process,” says Soenen. The integration of clinical operations and financial functions from “Plan to Cash”—ClearTrial’s marketing mantra—achieves speed and savings by identifying and eradicating only non-value-added process components.
ClearTrial Plan is the “prerequisite” to utilizing ClearTrial Track, since a realistic view of study progress depends on the objectives going in, says Soenen. The integrated product essentially allows decision makers to make informed choices regarding how to keep studies on track based on original budgets and timelines.
When dealing with clinical people, a fast and easy-to-use system like ClearTrial is the “cost of admission,” says Soenen. “We extended that with ClearTrial Track by incorporating a complex but proven project management technique, known as earned value management, tailored for use in clinical development.” Project health gets calculated automatically based on ClearTrial Track’s accruals management capability that derives costs from study-related tasks that need to be completed, as detailed in the initial project plan. It’s the same methodology clinical research organizations use to estimate their costs, albeit with an Excel spreadsheet.
Gloomy mid-study forecasts about project end dates and budget overruns can become the catalyst for change orders and protocol amendments that ClearTrial Track also accommodates, says Soenen. The product can easily reforecast and re-baseline studies that are underway while maintaining an audit trail of changes to assumptions and their downstream impact. The budget, resource/FTE, timeline, and unit price impact for the remainder of the study also gets automatically calculated.
“Trial sponsors typically have to engage their financial people to do their reforecasting,” notes Soenen. “Now, clinical people can do it. The software speaks to end users in their language and links clinical assumptions [such as added study visits or an extended subject enrollment period] to the projected financial and timeline impact.”
In addition to ClearTrial Plan and ClearTrial Track, ClearTrial’s “Plan to Cash” software suite includes ClearTrial Source to help accelerate the outsourcing function. Collectively, the three products provide the industry’s most comprehensive integrated management platform for clinical trials, says Soenen.
ClearTrial v3.0 includes expanded currency support and the setting of exchange rates, accommodating the shift to global clinical development, says Soenen.