By Deborah Borfitz

In a recently compiled market overview by Forrester Research, Phoenix Data Systems (PDS) got a high mark for integration but scored low in other important areas like safety and user experience. That assessment doesn't rattle Sam Hume, VP of technical operations. But it's a bit perplexing. "In terms of usability, we get excellent marks from sites," he says. "We've honed a familiar, Microsoft-like interface for years to make sure people can quickly use our software with a minimum of training and easily navigate the system. It's in our own best interest since we include all the user training as part of our basic service. If 'sexy' were the judging criteria, I might agree, but we get great marks from the people who actually use the software."

The truth is that many small and mid-size companies also prefer the vendor's dependable, responsive service-based delivery to the "expensive sizzle and rigid business models" of some providers, says Hume. "Phase Forward and Medidata are doing just fine, but mostly with super-sized companies that have the staff to support the application in-house and an army of data managers to keep busy. We're a better fit for companies that might not fit that profile, and we're more competitive for those companies who think that their only other choice is to go to a [clinical research organization]."

A few years ago, PDS wasn't even perceived as an A-list electronic data capture (EDC) player. Hume explains: "Until recently, we primarily relied on word-of-mouth sales. We didn't have the visibility and advertising budget of the public companies, so we were under the radar for a lot of people."

One of the primary PDS differentiators is that customers usually entrust it with the complete study build, often as a result of limited in-house staff to address the task, says Hume. "These companies tend to have no legacy infrastructures and therefore jump right to EDC. They also have fewer change management issues that come with size and bureaucracy."

Its application service provider-based offering is surrounded by a host of additional services to ensure that clients get all the benefits of PDS technology, even if they don't have in-house EDC expertise and IT support. "We're still at the point where it usually makes sense for PDS to have a large services role in building studies," says Hume. "Many clinical operations groups don't have much experience with capabilities like morphing forms [that change as data is entered], and they may not think to take advantage of things like cross-form edit checks [on data gathered earlier or imported from other sources] when designing their eCRFs [electronic case report forms]. We help them exploit the technology to the utmost." PDS Express also generates some safety reports and alerts for severe adverse events. Up-front planning and design helps to prevent changes that cause timelines to slide. It's vital with adaptive trials where, ideally, all changes are pre-meditated.

In the future, more studies will focus on post-approval safety surveillance, predicts Hume. "I'm not sure how fast we'll implement these capabilities at PDS. We can do safety monitoring now [focused on Phase I - III clinical trials], but do we need to do more? Do we need a separate system to allow customers to have a more formal safety system applicable across all studies? We're watching this trend closely."

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Deborah Borfitz is a Vero Beach, Fla.-based freelance writer who previously contributed to the clinical trials publication CenterWatch. She is co-author of Informed Consent, covering the risks and benefits of volunteering for trials.

Looking ahead, PDS is "particularly excited" about adaptive trial designs. "From a technology perspective, there are many similarities between adaptive and reactive changes," Hume quips. "The difference is the planning." At the moment, he believes that PDS technical performance and integrated IVR [interactive voice response] capabilities make it one of the few systems that effectively support these trials. "We can do randomization directly within our EDC system and we're working on how much we can automate dynamic adaption."

The FDA and statisticians are both appropriately intrigued by developments in this arena, says Hume. Most folks looking seriously at adaptive trials recognize that real-time reporting and visualization is critical. PDS combines both with its integration capabilities, providing trial managers with the "real time window, on all their data, that they need to manage these trials."

Related article:  Real-Time Trials, Bio-IT World, June 2006

BBK Worldwide recently packaged its 23 years of patient recruitment know-how into a suite of Web-based software, an expanded and enhanced version of its TrialCentralNet (TCN) platform, and spun it off as a separate company. There's a movement among sponsor companies to manage more clinical trial patient recruitment tasks in-house, making them "our largest competitors," explains Joan Bachenheimer, founding principal of Newton, Mass.-based BBK.

As sponsors are well aware, study enrollment is one step in the R&D drug development timeline than "can be significantly impacted by greater efficiency," says Bachenheimer. TCN e-Systems, BBK's new software solution, can help. Its six modules, paralleling the key risk areas for patient recruitment intervention, have been commercially available for eight years. But enhancements to the base platform are new and "concentrate more on accelerating time to market, based on the current needs of sponsor companies." They will, among other things, help sponsors evaluate site performance before signing a contract.

The Study Forecaster module, for instance, designs "what if" scenarios to help sponsors predict the needed number of sites and patients, as well as instantly create reports on everything from enrollment and drop-out rate to resource allocation. The Site Assessor enhancement provides a programmed survey that numerically ranks a site's ability to reach enrollment goals on time, says Bachenheimer.

The Site-Based Ad Manager, an enhancement to the Patient Generator module, allows sites to quickly get sponsor approval on advertisements and advise on where to run them. Another enhancement, the e-Clinical Study Finder, ensures a customer's study is placed high on search engine results pages. It was developed in conjunction with Orlando, Fla.-based optimization specialist DataBanq and capitalizes on the "moment in time" when the decision to participate in a trial is made, says Bachenheimer. Patients also get pre-screened and referred to study sites. It's an alternative to static, opt-in e-mail lists and Web advertising.

The Retention and Compliance module is designed to maintain study participation and compliance with the protocol and includes a means to display recruitment target numbers and dates. Newly accessible within the module is an online retention program catalogue that organizes patient appreciation items like calendars and wide-grip pens by therapeutic area and country-approval ratings, Bachenheimer says. Items can be customized and ordered by querying catalog options.

Each of the six modules -- Site Optimizer, Materials Manager and Approval Tracker, and Study Message Center are the other three -- has about five enhancements each as well as three to four "elective services," says Bachenheimer. This includes, for example, a BBK retention consultation. "Sponsors can use the software, hire us to use the tool, or they can use the tool and let us do the analysis. The idea is there's a partnership. It's like they say at Home Depot: 'You Can Do It. We Can Help.' "

The base platform is priced at $15,000 per trial, plus a maintenance service fee, says Bachenheimer. Enhancements run an additional $500 to $2,500 per trial, and referrals generated by e-Clinical Study Finder are $185 to $300 each, depending on the therapeutic area.