By Allison Proffitt

February 7, 2011 | ClearTrial has released version 4 of its “clinical trial operations” software, an update the company calls a “major upgrade” to the software-as-a-service offering.

ClearTrial 4 is not a clinical trial management system or electronic data capture, says Andrew Grygiel, VP of marketing and product management. The company prefers clinical trial operations—CTO—software, focusing on up-front trial planning, not execution. The SaaS product provides users tools to forecast, plan, outsource and track clinical trials.

“Ten years ago it was acceptable to have a variance of 10%, 15%, sometimes even higher [between budget and actual costs]. Folks would say, this clinical trial run is going to cost us $5m, and they could be off by millions of dollars. And while not desirable, that was acceptable,” Grygiel told eCliniqua. “Now budgets need to be in a tighter variance, because they want to make sure that every dollar is planned, and there’s very little deviation from the budgets that were set. So now, ten years later, [companies] are being asked to ensure that budgets come in with not greater than a 5% variance and some companies are even going lower.”

Grygiel says in the past this sort of trial forecasting was happening “on the back of a napkin” or in homegrown spreadsheets, but, “Those tools are no longer adequate to be able to handle this.”

ClearTrial allows users to predict costs associated with a trial, and ClearTrial 4’s newest feature, Task Manager, enhances the software's ability to create detailed study plans and budgets in minutes—with accuracy benchmarked to 95% or more from plan to actual costs—by providing biopharmaceutical and medical device companies with the flexibility to align the software to their unique study requirements and business processes.

The product is based on activity-based costing, which begins by deriving the level of effort for a specific resource (person) to perform a given task (activity). The level of effort is calculated based on an algorithm that has been derived from experience and analysis of the cost and time drivers that affect each task.

Users walk through a browser-based “wizard” of all the tasks and subtasks that comprise a clinical study to add, delete, and edit tasks—and their related resources and level-of-effort algorithms—with drop down menus and check boxes. Grygiel says that a quick budget can be drawn up in as few as 10 minutes, but users usually spend time trying different models and looking at the cost impacts of different options.

The calculations that run in the background are based on extensive, independent, and continuously-updated research into clinical study cost and time drivers.

“One of the things we always pride ourselves on is very extensive domain expertise,” says Grygiel. “This company is heavily weighted toward domain experts, clinical folks, folks who have been in the operations space, folks who have been in outsourcing, who’ve been in the whole financial management of a trial, project management of a trial.”