Since last fall, at a conference on the topic, anyone who loathes paper diaries for patients has been waiting for a signal from the FDA.

The agency promised to issue a guidance blessing the use of electronic techniques (either through a handheld computer or a telephone keypad) to record patient experiences in clinical trials. That promise remains unfulfilled, at least as a matter of public record.

But the agency has now notified an interactive voice response (IVR) vendor in Madison, Wisconsin, that it wholeheartedly endorses its general approach. The FDA's Tom Laughren wrote, in part, "HAM-D done by IVR would be one acceptable approach to obtaining these assessments." HAM-D is a time-honored tool to measure a patient's depression; HAM-D can be applied to paper diaries or more modern modalities. The FDA's letter does not express a preference for electronic over paper.

The back story is interesting. The FDA sent its August 4, 2004 letter to John Greist, M.D., and Jim Mundt, Ph.D., both of Healthcare Technology Systems (HTS). HTS, in turn, licensed its IVR tool for HAM-D to ClinPhone.

David Stein, ClinPhone's director of strategic business development, relates that while major trial sponsors are forging ahead with IVR and PDA-based studies, they're still privately hesitant about whether such technologies have deep support inside the government.

This new letter may help to erase that doubt. "Sponsors have been waiting to hear something like this from the FDA," says Stein. "We expect it will raise the comfort level for these instruments," meaning IVR, "but the implications go beyond these instruments," meaning Palms and other devices.

Early in December, for those needing to know more, ClinPhone will feature a webcast with Dr. Greist to discuss to discuss some of the ramifications and details. Bio-IT World will also be looking at this and other diary-related trends in a forthcoming issue.

Did anyone miss DataTrak's recent earnings report? Its backlog is surging. After being in the red, the company swung to a profit of roughly $400,000 for both the recent quarter and the first nine months of its fiscal year.

To quote the SEC filing: "Revenue for the nine months ended September 30, 2004 increased 55.1% to $7,892,000, as compared to $5,087,000 for the nine months ended September 30, 2003." The stock price has been steadily up since early 2003. I recently heard a vigorous rival to DataTrak compliment it as one of just four so-called "safe," IBM-like choices for electronic data capture (EDC) in the pharmaceutical industry.

Recently, DataTrak inked a deal with an unidentified customer that is, by its account, a Europe-based branch of a major American name in pharma. In a press release, Jeff Green, the company's president and CEO, called this company "visionary." Hmmm. That's not much to go on. (The sponsors of clinical trials are not exactly packed to the rafters with techno-visionaries.)

But having said that, Green's commentary in the press release is more interesting than most such documents: "They took the initial step and became trained as experts through technology transfer and then they extended this efficiency with another division across the ocean. Cross-continental data management would be difficult to do with paper because express mailing of case report forms halfway around the world would not make much sense. With EDC, virtual data management is instantaneously possible because all information exists in a live database, accessible anywhere in the world at any time. The ability to be 'EDC savvy' will soon become as much of a competitive advantage for data management teams as the ability to use spreadsheets is to the financial community."

Some would be tempted to swallow some antacids after feeling Larry Ellison's hot sailor breath on their neck. Others would throw a party. Bruce Schatzman took the latter approach.

President and founder of Advanced Clinical Software (ACS), Schatzman has attracted 1,700 registered customers since his company opened its doors in 1991. Few executives in the clinical technology sphere can say they have been at the same company selling the same wares for the same interval.

So when Oracle Clinical acquired SiteWorks, a company specializing in clinical trial management systems (CTMS), Schatzman had the gumption to suspect Oracle's prices would be sufficiently high to pose no immediate peril.

eCliniqua is not so sure about this - Oracle says it has been reaching out to academic users. But Schatzman believes Oracle is most ardently courting just the largest 30 sponsors of clinical research. He himself, in contrast, is wooing academic researchers, tiny labs, and major university centers trying to retaliate against the unstoppable force that is the contract research organization.

Schatzman is equally unfazed by Paraxel's Impact tool for CTMS or Phase Forward's application for electronic data capture (EDC). "It was never our intention to go up against Phase Forward and Oracle," he says. "That would be suicidal. That market is oversaturated as is. We give researchers the tools they need to conduct the research more efficiently, faster, and with better results."

Schatzman notes that many clinical investigators in the ivory tower have limited budgets from internal departmental or federal sources. Such scientists may use Excel or, I personally suspect, clay tablets.

"There is a whole new world of need out there, among both sponsors and the institutions that conduct the research," Schatzman says. Yes, it may be the low end of the market, but there are a large number of potential users. "There are thousands of them out there," he says. "We want to become the Microsoft Office of clinical research, not for pharmaceutical companies, but for healthcare institutions."

Schatzman says ACS's forte is two connected, powerful applications that help a lone physician-investigator or an entire academic medical center get their data in - at a reasonable price. The company has a Web-based CTMS and a companion program for EDC.

Depending on the trial or the campus, we might be talking about $1,500 per study and $500 per user per year. Or, in application service provider (ASP) mode, ACS prices out at $100 per user per month. This is not get-rich-fast money that would make most vendors salivate. Some of the top names in the industry charge $250,000 per trial. There is a Grand Canyon-wide gulf of opinion on what you get for that sort of money.

Meanwhile, some university IT departments - Schatzman mentions well-known universities in Connecticut and Vermont - have tried to produce EDC solutions during a year or two of heroic experimentation. "A lot of institutions have built internal tools. A lot of them have failed," says Schatzman ruefully. "You'll find many healthcare institutions are just getting started with EDC but can't justify to a hospital CEO or CFO why they should spend $250,000."

He's perfectly civil, but explains that IT departments in academic settings are as overburdened and understaffed as those in the corporate sector. Sure, these people want to help. But their software-development skills and domain knowledge of clinical workflows severely constrain them. Says Schatzman: "The IT people are very ambitious. They want to do interesting work and have job security. But they don't understand all the work that is involved."

Soon, he says, his company will offer something that sounds novel to eCliniqua's ears, although Schatzman insists it's not. ACS is about to roll out software to manage institutional review boards (IRBs). Two customers are about to test this application.

If this newsletter were mandated by a federal law to make a wild guess, it would hypothesize that around June 2005, perhaps by the next DIA, the kinks in this commercial IRB tool will be worked out, and the software will be sold to any willing buyer. Until then, this newsletter is in the rare position of actually liking the prospect of a new acronym ... IRBMS, anyone?

Here's how Schatzman says his IRBMS will work: "This is one user interface for both CTMS and a means by which an IRB can manage new submissions and approved submissions. You will enter your study in one place, and you can instantly begin to manage EDC and CTMS." Stranger things have happened. Should Larry Ellison be following in the wake of Bruce Schatzman?