For the contract research organization (CRO) serving multiple clients, it can be tough to stay abreast of multiple projects all over the world. In many ways, the technology advances of the past few years have made this more onerous, not less. The sheer number of systems with vital data continues to grow.

Veeda Oncology is hoping to use technology to its advantage. As a division inside Veeda Clinical Research, it’s a CRO with a focus on early phase, full-service cancer projects. It has U.S., European and Indian locations. The firm prides itself on speedy trial launches, usually in 2-3 months. To facilitate that, it recently decided to standardize on ClinPhone’s clinical trial management system (CTMS), TrialWorks. Veeda hasn’t used the system much so far.

Study Amendment+Site Payments=Chaos?

But Kathy Squillace, VP of global clinical operations at Veeda Oncology, says the CRO hopes that the CTMS will provide customers an additional level of comfort that key details will be available. “It attracts sponsors,” she says. “You don’t need to explain how your proprietary or homegrown system works. All those questions go away.”

“What we wanted was a state of the art CTMS that would effectively track, manage and provide reports globally,” she adds. Having an easy-to-use system was a priority. Says Squillace: “If you have a system and no one wants to use it, there is no point in having it. We had looked at some larger vendors. I didn’t want something that would take many hours for each project to set up. This was very user friendly.”

Veeda also inspected the ClinPhone CTMS for its ability to manage payments to clinical investigators. In that area, the firm didn’t just want to send a request for a check to a separate financial system. It wanted the ability to have different payment formulas, including holdbacks, for different investigators—even, Squillace says, different ways to pay the same investigator after a trial or contractual amendment has shifted the terms of the arrangement. “A number of CTMS systems do not do that,” she says.

Remote Access

At Veeda, the need for granular tracking of payments had occasionally forced the company to use Microsoft Excel. “If you don’t have something like this, you end up doing it on a spreadsheet. But we wanted to get away from that,” Squillace says.

She also liked the monitoring module. “Monitors can have access to the data while they’re at the site,” Squillace says. “I’m hoping that makes their lives a little easier.”

It’s not news to Squillace that monitors have a lengthy list of things to accomplish every day. She’s hoping the TrialWorks system will simplify life. Says Squillace: “It’s difficult for people when they’re in the field and don’t have access to certain information. I think this will make their lives easier. We don’t want people to be burned out. We want to make their jobs easier.”

Fast Startup

At ClinPhone, meanwhile, the technology vendor says the CTMS landscape is in a bit of flux, with some of the users of the largest systems (Oracle/Siebel, Parexel/Impact) in a tire-kicking mode. Access to real time access, as with electronic data capture, is something more sponsors seek, says Sara Diamond, ClinPhone’s VP for CTMS development.

In keeping with Veeda’s interest in speed, Diamond says her CTMS can be set up with trained users in about a week. Some customers opt for a bit of consulting from ClinPhone as well.

Make It Easy

In some cases, she says, CROs are selecting a CTMS because a competitor is touting the usage of one. “As they’re seeing that, they want to be able to say that and join the bandwagon,” says Diamond. “CROs should be touting the systems they use. If they’re not confident using those systems, perhaps they should be looking at others.”

On other occasions, Diamond says, understanding what some customers don’t necessarily love about their present CTMS is part of the ClinPhone sales process to roll out the technology it acquired in 2004. “We do see those end users as part of the selection process,” she says. “If they’ve had a poor experience in the past, we wouldn’t want that experience to carry over.” Some CTMS are pushed down from senior managers with little understanding of how they will be used, as Rob Musterer wrote here on this site.

On the mundane level, Diamond says monitoring preferences can be set using Microsoft Word templates; there’s no need to fuss with PDF documents that are hard to import or edit. “If the user makes a mistake, they’re left with a PDF that doesn’t accurately reflect what they’re doing,” Diamond says.

Enabling IRM

Diamond says ClinPhone is trying to position itself squarely in the middle of the push to treat investigators more professionally. A while back, ClinPage had a series on the investigator relationship management (IRM) craze with articles here (Quintiles), here (Sanofi Aventis), here (Wyeth), and here (Lilly). The norm in the industry, of course, is that an investigator gets a check in the mail and has no idea what it was for. More detail about payments is built into the ClinPhone CTMS.

Diamond says that it should result in fewer investigators feeling resentment toward the sponsors that need them. “They’re going to look at that and be happy. They’re going to feel that what they’re being paid for is accurate and they’re being fairly compensated.”

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