The clinical trial technology landscape is consolidating, with firms buying each other or limping along.

In that context, last month’s rebranding of the safety software of Phase Forward is interesting. To quote the press release: “Phase Forward is unifying its safety products under a new product family name—Empirica—for its suite of pharmacovigilance and risk management products.”

The move appears to be an effort to re-ignite interest in the vital but sleepy drug safety software sector, a niche that (in Phase Forward’s case) has yet to contribute a significant share of revenues to the Waltham, Mass., firm. As much as anything, that’s a reflection of rapid growth in electronic data capture. But as sponsors of clinical trials seek to connect trial systems and processes, the safety and pharmacovigilance elements of the Phase Forward toolbox are unique assets, and the company apparently decided they needed a catchier name.

Safety Systems

For now, the sole product with the new verbiage is Empirica Trace. Formerly known as Clintrace, that software was part of Phase Forward, not Lincoln Technologies, though some members of the Lincoln team had familiarity with it.

“The Empirica suite will grow to cover more and more of the products,” says Chan Russell, the division’s president. He came along with the company’s $11 million acquisition in 2005.

Automatic Reports

Empirica Trace helps code and manage adverse events—and the attendant reports about those events. It’s no longer necessary to manually generate reports, which in organizations of any size can be complicated by both internal stake holders and regulatory agencies that need to see such reports.

Once an organization figures out who needs to see which reports, the Empirica Trace software can send them automatically. “The system knows at a detailed level what your reporting plan is. You don’t have to manually look up for each case who does this type of case go to,” says Russell. “It makes it more likely that you’ll meet your delivery requirements and timelines.”

The software supports the increasingly important E2B and E2C standards, and can submit a variety of types of Medwatch, ICH, CIOMS and other types of reports electronically or by fax. Leading medical coding dictionaries are supported.

Case Management

There’s also an ability to watch cases prior to them being formally designated as adverse events. “You want to be able to get them in, do searches, see if it is duplicate or follow up,”  says Russell. That represents a smarter way to handle specious cases or things that properly belong in some other process like product complaints. “You don’t want to do the thing that people think they want to do, which is ‘let’s make it a case.’ You don’t want the tracking burden of making everything a case.”

The software has long had Cognos business intelligence reports built in. Now there’s new functionality to allow insight not just into adverse events, but an organization’s overall efficiency in managing data as it moves through the pipeline. “People want to do operational queries for getting a better picture of how their processing is working, and how long things stay in various states,” says Russell.

When ‘60 Minutes’ Calls

In some cases, Russell says, better technology will allow a more responsive response when a professor makes an allegation about a drug or medical device. “Your window for responding to those things tends to be relatively short,” he notes of cases in which academics do their own analyses of data in the public literature and arrive at different conclusions than sponsor or FDA experts. Indeed, the competition between TV, web and other information outlets means that industry views can be ignored if they take days, weeks or months to be formulated inside governance-rich environments in the life sciences.

Russell has a more delicate way of phrasing that: “If you’re off working on it forever, you’re not going to get much attention when you come up with your analysis. The time lines have gotten shorter. You need to be able to draw on the data you’ve got and get a response together. You can’t begin the integration problem when the crisis arrives.”

The industry is inching toward more unified drug safety solutions, he contends. “Customers increasingly view the safety domain as a whole and want to move more flexibly in it. Rather than as discrete applications that don’t have an easy way of moving from one to another.”