Tim Pratt cut his teeth in the world of medical devices, at Guidant and Medtronic, where a defibrillator can record 2,500 different variables. Fashioning a career out of working with such surging rivers of data, he landed at MedNet Solutions, where his title is chief marketing officer and principal scientific advisor.

If you ask us, having interviewed Pratt a few times over the years, he’s having a little too good a time. Is it fair that someone relishes their work with such unabashed delight? Not really. But it makes it fun to talk to Pratt, who’s a nurse, a PhD, and an inventor with patents under his belt.

For those not familiar with it, MedNet is a clinical trial technology platform that includes electronic data capture (EDC). But its system includes functionality for clinical data management, clinical trial management and document management. There is no batch processing of data over night; it’s all happening in real time in a browser window.

Technology Suite

Although he’s based in Minneapolis, where the shy folks are as easy to find as corn, Pratt is anything but meek—a vestige, perhaps, of his Australian roots. He makes no small claims for his system. “People who use our technology get very clean data,” he says. “It’s a reduced training burden. They tend to enroll quicker and faster.”

After a recent conference, he noted, “We had two dozen end users go out of their way to come up to our booth; they all said this is the easiest system to use.” The privately held MedNet releases no financial figures. Pratt says it’s profitable, without burdensome debt or nervous venture capitalists second-guessing key decisions.

Clinical Home Companion

MedNet’s solution, Pratt notes, is priced 25-50 percent lower than that of his most prominent competitors. He says several of the biggest EDC firms in the industry have a limited ability to serve all their customers at the exalted levels that sponsor companies expect. That, Pratt believes, creates an opportunity for MedNet.

“Generally we don’t hear good things,” he says of his largest rivals. “We hear pretty unpleasant things about responsiveness, out of scope charges, and unwillingness to configure the product to the customer’s design. We pick up those people. They end up very, very happy.”

MedNet counts Abbott, Allergan, Boston Scientific, Medtronic and AstraZeneca as customers. “Most of our customers come back for more,” Pratt says. “They really like the system. Somewhere north of 85 or 90 percent is repeat business. Our biggest problem is awareness. Just people knowing who we are.”

’Cleanest Data’

The company has a healthy business serving pharmaceutical companies of all sizes. But half of its business is from medical device manufacturers. MedNet, it turns out, has a certain virtuosity in corralling data from disparate devices, which may have different physiological applications or proprietary data formats coming off them.

Pratt clearly loves MedNet’s complex projects. “It’s the cleanest data in the world,” he says of the information coming off medical devices. “It’s never been touched by human hands. It’s purely objective and nobody has messed with it. Medical devices offer you more capability to do really fancy things than you may necessarily do with a drug.”

Merging Magic

In a project with pulmonary gas exchangers, MedNet figured out a way to take data from devices manufactured by eight different companies and put it into the same database. Every one of the eight formats was unique.

Better still, because the data had to be analyzed by experts, the system allowed the data to be reviewed in a normalized and consistent way across the trial. “This is all happening in a highly automated fashion,” says Pratt. “If you’ve had to mail hard copies of this information to different investigators, you’d know how much of a problem that is.”

The MedNet system is configured to generate to-do lists automatically, even for other organizations that are partnering to support a trial. That helps a project stay on track. “Everybody knows what they have to do, when they have to do it and when it’s been done,” says Pratt. “You can deal with it before it becomes a problem.”

‘Out Of Their Mind’?

As noted above, MedNet’s solution encompasses clinical trial management, clinical data management (CDM) and project management, down to the level of institutional review board documents and payments to investigators.

Pratt doesn’t think that any EDC system worth its salt should omit a clinical data management component. “I would not buy an eclinical solution that didn’t have some form of CDM system embedded in it,” he says. “Anyone who buys a standalone CDM system is out of their mind.” EDC systems still lacking such functionality, he predicts, will be marginal or dormant products in the near future.

EDC + CTMS

Indeed, the embedded clinical trial management system (CTMS) functionality in his system is a key differentiator. “There will always be a market for standalone CTMS,” Pratt says. “I just don’t believe they’re very good.”

As an example of what his system can do, he describes its ability to automatically monitor the expirations of clinical investigators’ 1572 forms. The MedNet system can be configured to issue alerts by email or fax; the sponsor can be copied on such correspondence. If the sponsor specifies it, the system can prevent investigators from putting new patients into the system until the paperwork is in order.

eIRB Management

Here’s how Pratt explains the web-based system, which will flash reminders to investigators who need to update their forms. “It will keep on sending them email or faxes or both until they hit the link. All those notices are tracked on an individual basis. You can have it copied to yourself or other personnel so you really know it happened. For regulatory compliance purposes, if they get to their renewal date, and they have not given you their document, the system can automatically suspend their enrollment. It will send them a notice, ‘We love you to death, but you’re not putting more patients in.’”

Pratt notes that one current customer, based in Texas, was distressed to learn that a low six-figure project with a well-known customer relationship management solution would still not do what his system offers out of the box.

Pratt is realistic enough to know that investments in such standalone CTM systems will not be abandoned lightly. But he also knows that a customer’s residual frustration or disappointment can be a potent force for long-term assessment of options that are natively full-featured for clinical trials, and not generic business tools that have been adapted for the space.