By Mark D. Uehling
October 15, 2003 | The rap against some contract research organizations (CROs) is that, technologically speaking, they have a lot in common with the Amish. They're happy to stick with what works, harvesting clinical data with pitchforks and wheelbarrows even though more advanced equipment is on the market.
Now Numoda, based in Philadelphia, has finished 60 trials. It is aiming to dismantle the stereotype of CROs by beating leading players in electronic data capture (EDC) at their own game. "We are a CRO and a new kind of a CRO," vows Ann Boris, Numoda's chief technical architect and head of clinical operations. "Our specialty is the automation of the clinical trial process." If its claims pan out, Numoda could give both larger clinical software vendors and CROs a run for their money.
Utterly paperless, the Numoda process has an electronic interface that combines several types of data: from not only the clinic, but also the hospital lab, doctors’ offices, radiology, the pharmacy, even from warehouses shipping drugs. "It's all about electronic source," Boris says. "We do a completely integrated trial," with a single Web interface at the sponsor site, but not at the clinic. There, wireless, battery-powered devices are the rule.
Boris says both laptops and desktop computers are superfluous at clinical sites in the United States (where desk space is tight) and in developing countries (where telecommunications are poor). "We had some good experiences with [Numoda]," says Adriano Martins, who helps manage clinical trial data for Eli Lilly in Brazil.
Running trials in places like India and Romania taught Numoda that mobility and simplicity are everything. "Even the laptop is an aggravation," Boris says. "They need the battery-powered tablets." She says the sheer ease of the technology contributes to rave reviews from sites. "Because we're paperless and we're portable," she says, "everyone we've worked with us loves it.”
The only routine aspect to Numoda as a CRO is that, like other companies in the industry, it has an aversion to technology for its own sake. The IT cart is placed squarely behind a reliable, results-oriented horse. "The basis of our business is our services," Boris says. "That is what makes us so sound. Our software is something that makes us even more sound, in that our services can be priced better and delivered better."
Anecdotally, the company says in some trials it can triple the customary recruiting rate of 1.4 to 4 patients per month per site. In its trials, Numoda says, it typically lifts those numbers to 8-12 patients per month per site. If that performance is easy to replicate in other trials, Numoda has apparently gone a good distance toward solving the most intractable problem in clinical trials: enlisting qualified patients in sufficient quantity.
None of the company's customers (which include Johnson & Johnson, GlaxoSmithKline, Novartis, Abbott Laboratories, or their CROs) were willing to testify at length about Numoda. But Boris says her company is saving sponsors significant sums of money simply by running lean and speeding the recruitment process. One Japanese client asked Numoda for a quote and expertise, and, Boris says, "We were able to save them 35 percent, just in the budgeting and bidding process."
Competition does not worry her. "There's plenty of work for all of us," she says of the CRO industry. Boris concedes some customers are a bit spooked by what some clinical IT vendors have promised and not delivered. "When we come in, we're talking to people about buying clams" -- she pauses -- "and they've just had bad clams. There are definitely questions about results." In one large company alone, she believes, four different division heads are fretting about lack of results from EDC.
The Numoda philosophy is different. "It's about collecting the data, reporting them, and doing that in an efficient and cost-effective manner so you can do more scientific work. Are you taking out the manual paperwork? Are you integrating it so that it makes it efficient so that you can do the scientific work?"
For now, almost half of the company's business is overseas. Numoda has 60 employees in Philadelphia, India, and China. "There is actually no limit to what you can do if the technology scales well," Boris says, noting that the tablets and handheld devices can all be configured remotely. "We can configure and deliver the trial -- case report forms, protocols -- remotely. "