ClinPage just spent a few days with the etrials user community, a tight and festive group. There was a fair level of excitement and anticipation for changes across the company’s platform.

There was no hype or grandiosity at the etrials conference, just straight-ahead details. The North Carolina vendor has successfully engineered a digital makeover to make its users’ lives as easy and simple as possible.

CEO John Cline started the meeting off by noting the company’s transition to a publicly traded firm. “2006 was an extremely busy and exciting year,” Cline said. “Our clients are using multiple technologies from us. Integrated clinical technologies are the future.”

Indeed, more than a few of Cline’s rivals have announced or are about to announce new EDC functionality that takes on the duties of systems that once seemed far afield from electronic data capture (EDC), the core piece of the etrials suite. More on that in a moment.

Emphasis On Service

Cline noted the rapid growth in head count had required additional turkeys for the company’s annual barbecue. But there was also a somber note. “Growth can be painful,” Cline said. “We have hit a few road bumps in terms of our service offering. We recognize that.”

The company increasingly will stress ... service, with a redoubled effort on that front. It boasts an internally run customer support center that is staffed 24/7/365. Cline pledged to have etrials personnel pay face-to-face visits to customers on a quarterly basis. The code word is fanatical. “We believe we must be fanatical to take care of customers,” he said. “We are raising our service levels. Let’s not let molehills become mountains.”

As the meeting illustrated, etrials has already been working closely with a new breed of contract research organization (CRO). Unlike some of the very largest CROs, this breed is proud to partner with an EDC firm, understanding that the benefits of technology (in terms of dollars and efficiencies) will also flow its way. That was an eye-opener.

Three Easy Pieces

Next up at the podium: Chief strategy officer Rick Piazza, the chief technology wizard at etrials. He noted that the company has three main product lines: diaries, IVR and EDC. All are changing.

On the e-diary front, Piazza said etrials can now handle mid-study changes remotely, over the telephone. “We can implement remote mid-study changes,” he said. “We don’t have to send devices out or use little memory cards.”

etrials is also in the final stages of testing a program to help just with the logistical aspects of deploying thousands of handheld PDAs around the world. It will help the company track the gadgets internally. The time to test a device will be cut by 70 or 80 percent.

Tracking Drug Supplies

With regard to its IVR application, etrials reminded the audience that its solution is integrated with the internet, making it an IVR-interactive web response (IWR) system. Sites and sponsors can decide which system to use. Sensing competition, perhaps on the drug-supply management front, etrials is shortly hoping to add the ability to track shipments of pills around the world.

The main event, of course, was Piazza’s discussion of the new EDC system. The company apparently feels some demand from users for an infinite variety of tiny logos for this field or that purpose. It is resisting that pressure, with a goal of keeping things as simple as possible. For this revision, etrials hired a user-interface (UI) design firm for the first time.

The company wanted to freshen the look of its application. “By bringing in a third party, it gave us a whole new perspective on things,” Piazza said. “What we’ve done in EDC v. 2.0 is change the look and feel to be more in line with web applications you see today. It looks much more modern than the tool we currently have.”

Clean Look

Piazza says the UI consultants were pesky, repeatedly pushing to be able to do any particular clinical task in two clicks of a mouse. Not four or five. 

Piazza conceded that the former version of the product could not quite give the user a clear view of everything. “You didn’t really get a good snapshot of everything you were looking for in one shot,” he said. “If you want to see all the queries in one place, you can—or just the open ones, or just the closed ones.”

So now there is a new dashboard, with differing views that depend on the user’s role and access privileges. Simple hyperlinks lead to additional views organized by site, patient, case report form or data clarification form. Monitors have access to multiple sites at one glance.

It’s possible to generate your own reports and to export the EDC data into Excel or PDF formats. The system can be configured for individual sponsors and trials, Piazza says. But he’s trying to avoid the word customize.

Explains Piazza: “People think that means the programmers have to change the code to get what they want. It’s really configurable by you.” Demonstrating the idea, Piazza showed the audience how to turn off source document verification in a registry project.

Self Administration

As etrials announced, it’s killed a separate program to administer its EDC tool, and folded it into the EDC application itself. “We’ve built administration into the EDC application, which I think will be very popular,” Piazza said.

With simple check boxes and other features, the goal was to let users control the technology to the degree that a particular trial would require. “We’re getting rid of things that are not necessary, but making them available when they are,” Piazza says.

One of the surprises was the degree to which etrials (as well as other companies in the EDC space) have their eye on encroaching on the territory of clinical trial management systems (CTMS).

The purveyors of such systems may or may not be flattered. “We are going to start bringing in more CTMS features into EDC,” Piazza said. “We’ll continue to add more metrics and information that is more study management information.”

Key Changes

Officially, verbatim from the company, here are the highlights from etrials’ EDC v. 2.0 revision:

•Embedded administrative tools for easier user, site, and study management

•Role- and permission-based configurations

•Configurable functionality (on/off) to support different study types

•Automated workflow to optimize common and frequent tasks

•Enhanced real-time reporting and analytics for quicker and more informed decision making

•Intuitive design and navigation to enhance user experience

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