etrials has been going through a rough patch. The company’s founder, John Cline, left a year or so ago. Then his replacement also left the firm. As did the chief financial officer. Now there’s an interim president and CEO, Chuck Piccirillo. It sounds like the Morrisville, North Carolina, firm is aware of the challenges ahead but confident about its future.

“We continue to focus on our transformation,” says Piccirillo. “It’s no secret etrials has gone through some changes. The executive team is a strong team with extensive experience in the software and service area. I don’t think the outside world necessarily sees or appreciates that. My intent is to lead the business and strengthen our capabilities around being an eclinical solutions provider.”

Target: Middle Tier

etrials is targeting mid-sized sponsors in the pharmaceutical and biotechnology sector, he reports. Those companies are not yet as committed to specific technology solutions as big pharma.

The etrials suite can solve several problems at once for sponsors. It includes tools for electronic data capture (EDC), clinical trial management, and interactive voice response. Thanks to changes in the etrials sales force, both in approach and personnel, the company is starting to see some traction in the market. Its order backlog grew 23 percent since June, 2007, but revenues have not yet appeared. The company reported a $2.2 million loss in the most recent quarter. It has $14 million in cash on hand.

Looking ahead, etrials recently reported 35 new contracts, including 29 with existing clients and six with new clients. A third of the new engagements will use more than one technology. That’s a signal some sponsors may no longer enjoy the cumbersome work of tying disparate technologies together.

Diaries In Demand

One of the bright spots in the story is e-diaries. The company’s electronic patient-reported outcomes solution used Windows-based devices years ago, insulating sponsors from ongoing concerns about the viability of the Palm platform. “It’s a key element for our strategy and where we’re taking our suite,” Piccirillo says, noting the diaries are already integrated with the company’s other solutions. “It’s a strong element of our strategy and well-received by our customers. It connects our patients more tightly from a data perspective in with managing the clinical trial.”

The company re-engineered its EDC software a few years ago. Piccirillo says that product is another core offering. “We have gotten very good feedback relative to its flexibility and ease of use, both functionally for users and for the way we implement it for customers,” he says.

Tying It Together

We recently published a list of 19 major eclinical suites, each offering more than three major types of software required in industry-sponsored clinical trials. etrials is on the list and was an early proponent of the strategy. One question hanging over etrials, DataTrak, ClinPhone and other advocates of the approach is the degree to which sponsors still prefer the best-of-breed approach, or are starting to experience pain in linking so many technologies from so many different providers.

For his part, Piccirillo says that the maturation of software in other industries has invariably involved more than just one application. SAP and Oracle are classic examples. But the hospital industry, to take another, has felt frustration around having isolated islands of computer programs and data; it has spent billions trying to connect those systems. Says Piccirillo: “For clients to be able to derive the true value they are trying to get out of these application suites, it is not going to be derived without leveraging integration services.”

Integrating clinical trial systems has a variety of definitions. But it is never for the faint of heart. And the benefits are potentially of strategic and commercial value to the organizations that can harvest information that is now getting lost in the gaps between systems. Companies that can truly connect systems managing, say, randomization and clinical data management may have the ability to adjust the course of a trial before it encounters difficulties.

But many trial sponsors, in 2008, don’t know what they don’t know. “We refer to it as actionable information,” Piccirillo says. He believes that it will be difficult for sponsors to get everything they need for a trial from a single technology provider. Even with robust medical imaging systems, he notes, there is room for a variety of providers.

Industry Direction

Sponsors are starting to ask about more than one application per trial, he reports. That could oblige etrials and its competitors to begin considering how easily all of the tools in one company’s arsenal can be united—and, of course, how readily they can be mixed and matched with those of other firms. Shifting alliances and rivalries with both technology firms and contract research organizations add a new layer of complexity to the terrain.

Piccirillo isn’t necessarily predicting an immediate surge in demand for eclinical suites. Rather, he says, sponsors will look to a small number of firms that have several core, connected systems—and build out from there. “It’s key to be able to look to a vendor that not only has a number of solutions but the ability to integrate those solutions,” Piccirillo says. “I wouldn’t recommend they do it themselves.”