Phoenix Data Systems (King of Prussia, Pennsylvania), which provides electronic data capture (EDC) systems for clinical trial sponsors, has increased its offerings by expanding its eClinical Trials Data Management Services for Phase I-IV at the same time it is seeing the demand for its offerings grow.

Earlier this month, the company reported the launch of PDS IVR, an interactive voice response system also supporting Phase I-IV clinical trials. And it is now offering a single point-of-contact for clients with Phoenix and training services for those who work on the trials to collect data or have other responsibilities for managing the trial.

“All these things are really building our message,“ Jim Dorsey, marketing director at Phoenix Data Systems, told Medical Device Daily. “We always tell people we are extending the control that we give sponsors, and the services are intended to give them trained personnel who can use the tools, as well as – in the case of IVR – an additional electronic data capture tool that's integrated with our usual EDC.“

Though the company did not announce the IVR system until earlier this month, Phoenix has had customers using it in advance. Before offering its own IVR system – which allows participants in a clinical trial to call in the required information being collected by trial sponsors – Phoenix integrated its own EDC system with other vendors' IVR systems.

The technology, which is accessed via telephone networks, delivers randomization for clinical trials and to gather patient-reported outcome data. PDS IVR uses touch-tone keypad selection to interact with callers and then provides “appropriate responses“ in several forms, including voice, fax, callback or e-mail.

Gathering this type of subjective information when a patient self-reports on his or her well-being is called electronic patient reported outcomes, or ePRO.

“By integrating ePRO data directly into an EDC database, sponsors can easily corroborate the findings of clinical studies with subject assessments,“ Phoenix said. “Patient-entered data can be subjected to the same rigorous edit check processes as study-entered data.“

IVR is also designed to ensure sponsors that such reported data is “stored in a secure, regulatory-compliant repository.“ And it allows patient data to be transferred directly into EDC case report forms, the company said.

The training component of Phoenix's offerings involves assigning a so-called “project champion“ to a specific clinical trial sponsor to help the sponsor navigate the EDC system.

Dorsey said there is an important reason for this – that clinical trial sponsors, when adopting an EDC program, often feel as if they are “losing control of their data to some extent.“

“They were turning it over – outsourcing it – and they just have to sit back and wait for the answers,“ Dorsey said. “They couldn't see what was happening in between.“

This training component also grew out of company discussions with a client advisory board meeting late last year. This produced the request that Phoenix “take on more responsibilities“ while allowing the sponsor to maintain “that sense of connection to the trial,“ Dorsey said.

“What we really believe is what distinguishes us is our ability to give better control over the trial, and that is the core of what we do,“ Dorsey said. “The services and the tools are all about connecting the sponsor to the trial as it happens, so providing them with real-time access to the data.“

The “project champion“ acts as an advocate for the sponsor and gives the sponsor client a single point of contact for any problems or concerns. Dorsey said that is a benefit to many clients, who are accustomed in many cases to a model of outsourcing or technical model that's built on change orders, or changes in requirements that may add to the cost of the system for the client.

“What sponsors have told us is [an unexpected change] drives them crazy,“ Dorsey said. “They have their own internal processes they need to go through, they're trying to control the budget, and this is just one more hurdle – or one more complication – in an already complicated situation.“

And clients are responding favorably to the new initiatives that Phoenix has under way for this largely untapped market. For example, Dorsey estimates only 20% of trials in 2005 utilized EDC, and perhaps even less than that.

Even at 20%, that “still leaves an awful lot of room“ in the market, he said. The company expects that over the next five years, anywhere from 60% to 75% of clinical trial sponsors will use EDC. Another example of the company's growth is that earlier this month it was at 63 employees, 50% more than a year ago.

“What we think is that 2005 was sort of a 'tipping point' or 'crossing the chasm' or whatever your favorite analogy might be,“ he noted. “That was the year people stopped asking us the question of 'Why do I need EDC?' to more of, 'Tell me why your EDC [system] is the one that I need?'