By Paul Thomas, Senior Editor

Editor's Note: Why don't clinical trials finish on time? For a DecisionView white paper, click here.

As the world of drug development and manufacturing goes paperless and incorporates electronic data management into its best practices, the area of clinical trial recruitment lags behind, says Steve Andrade, CEO of DecisionView, a software provider based in San Francisco. Many pharmaceutical companies track their trials manually, or with customized Excel spreadsheets. "There are not a lot of predictive capabilities or opportunities to leverage data," Andrade says.

Naturally, Andrade aims to change that. DecisionView's cornerstone product is StudyOptimizer, software that, the company says, is the first web-based application developed for clinical trial recruitment and enrollment. StudyOptimizer allows a company to capture—either in real time or, say, on a daily basis—how it is doing in recruitment and enrollment at all sites relative to planning. And it allows clients to adapt and adjust strategies across sites—like a "digitized sandbox," Andrade says. The software can be hosted by a client's own server or, as is becoming increasingly common, hosted by DecisionView.

Trial recruitment and enrollment has been "screaming" for greater automation, Andrade says. At most companies, there is very little visibility into clinical trial practices worldwide. One current client is recruiting thousands of patients for a European trial. "We're providing a projection as to whether they'll be completing enrollment at the end of the intended period," Andrade says. "We let them know which sites are tracking ahead and behind."

GlaxoSmithKline has had a good experience using this application, Andrade adds, and has been able to maintain greater discipline with its trials and track metrics important to the industry—speed, cycle time, productivity and hard costs. "They have essentially adopted StudyOptimizer globally, and have been able to run a lot more studies according to plan" and to improve assumptions about the continued progress of trials, he says.

There have been several drivers for the product, says Andrade. The first is that many companies have CEO mandates to improve productivity in all areas—clinical trials are no exception. Cost reduction is also critical, and any product that leads to improved oversight and better lifecycle management and time optimization will lead to cost savings. Finally, Andrade says, "most companies are speaking to us about the quality element. There is a lot of inconsistency and uncertainty that a process is executable, so we help them to enable a consistent, repeatable quality process."

In time, DecisionView plans to branch out into other areas of clinical trial automation. The company is still honing StudyOptimizer's capabilities for predictive analytics and modeling. Improving companies' future trial site selection is just one obvious outgrowth of this effort.

Down the road, the company hopes to become a solutions provider in the areas of clinical trial budgeting and forecasting, and clinical supply management. There have been significant and encouraging strides made in the digitization of clinical trial data and in trial management, Andrade says. "But there's still a lot of opportunity that exists. Unfortunately, there are still a great number of practices that are very manual in nature."