We read a surprising statistic the other day. According to market research firm NPD Group, Apple’s iPhone has blazed past Microsoft and Motorola in less than a year, capturing 16 percent of the smart phone market. It’s now second only to the Blackberry from RIM. Among all cell phones, Apple’s device is in the fifth spot.

Our contrarian opinion, for the record, is that Steve Jobs has mismanaged the Apple computing platform. He’s foisted on his faithful, among other things, a buggy browser, an awful hard-disk search utility and trips to the Unix command line that make repairing an infected PC feel like a day at the beach.

Still, there is a “wow” factor with the iPhone that is spilling over into the clinical trial arena. As we wrote a while back, Nextrials announced that its electronic data capture (EDC) system functions perfectly on an iPhone, which has a built-in web browser.

In the electronic patient-reported outcome (ePRO) world, most of the big suppliers for industry-sponsored trials are quietly providing alternatives to Palm hardware. (Firms offering Windows devices for clinical trials include PHT, etrials, and CRF.)

Wounded Palm

Palm ain’t dead, we hasten to add. Even Apple does not have a way to fluidly get information into a smart phone that compares to the ease of use of the Palm Treo.

But Palm is nevertheless a victim of the iPhone’s popularity. (Here’s a Blackberry-centric view of what’s happened to Palm.) Palm’s future is murky, given a decline in revenues and larger, more adroit rivals in the U.S., Canada and Europe.

That brings us to .assisTek, where Gary Coraggio is a VP. The 13-year-old Arizona company has long specialized in helping clinical sites. It doesn’t use hardware from Palm. AssisTek has helped on 100 trials in 27 countries in 35 therapeutic areas; its specialty is studies of pain medications. The firm puts a period in front of its name, and was formerly known as Assist Technologies.

You can see a screen shot of some products here. Market conditions are good, Coraggio notes: “We talk to a lot of companies that are telling us that they are moving away from pencil and paper in the next two years. We are the global leader in this area of touch screen tablets.”

Big Screen

Coraggio says there is a simple pathway to validating its flagship tablet, the TouchPro, that need not compress a paper questionnaire into a tiny screen on a smart phone. That’s just because the screen is so big.

“You can get questions and answers on the same screen, so you don’t have to scroll,” says Coraggio. “It eases a lot of the validation concerns. There needs to be little or no modifications from the original questionnaire.”

assiTek TouchPro

AssisTek announced support for the Apple iPhone earlier this year; here are some screen shots.

PRO goes Pro

In general, assisTek does not sell but leases hardware to sponsors. That keeps costs down and prevents the need to manage untold boxes of devices to be stored at the end of a study. AssisTek worries about that.

The sponsor community, Coraggio reports, is starting to take electronic patient reported outcomes (ePRO) more seriously. “Director of PRO is a new title that we are seeing pop up,” he notes. “This seems to be a person who’s helping oversee the whole scope of things. That’s something that’s definitely exciting.”

And while the company has adapted the iPhone for clinical trials, it has not signed any contracts to provide them yet. AssisTek believes it is the first firm to offer a specially configured Apple product for the pharmaceutical industry. Says Coraggio: “We have been out at shows and had the devices. Our competitors have stopped by. No one has said, ‘we have that also.’ ”

A Clinical Apple

Some of the iPhone’s functionality will be turned off to ensure a validated, 21 CFR Part 11-compliant device: “There are many functions that the iPhone provides to consumers,” he says. “We would be probably closing most of the other features.”

Coraggio says that while a touch screen is not a novel feature, the general ease of use of the Apple device will be relevant in a business context that places significant demands on sites and clinical research associates. Outside of large corporations, he says, most ordinary citizens dislike the stylus that comes with every Palm.

Apple’s screen, famously, works in a horizontal or vertical orientation. It can be navigated with a finger tip. Sites that are on the fence about participating in a trial might be tempted to use the device, he speculates. “When we show it, people are intrigued by it,” he says. “The iPhone is attractive—a cool, sleek and fun thing to use.”

Quick Bids

Like many observers of the sponsor community, Coraggio notes that it may not always have a precise understanding of the sheer burden of paper. “A lot of companies really don’t have a good way of capturing what it’s been costing them, whether it’s been in-house or with a contract research organization,” he says.

By virtue of assisTek’s familiarity with the terrain, it can quickly assemble cost estimates for PRO projects. Coraggio can typically ask just five questions and prepare an estimate in 24 hours.

The company has developed a 30-element Excel worksheet that can help tally everything up. The spreadsheet shows a sponsor (or a CRO) what it really may be spending to correct and manage paper documents. The spreadsheet “can be populated by the sponsor,” says Coraggio. “Or we have done it for them based on our experience. We’ve been showing pretty tremendous savings using our system over pencil and paper.” In some cases, he says, those savings can be an impressive 50 percent.