Rapid growth in the electronic data capture (EDC) industry is unfolding. If it resembles other sectors of the technology space, a handful of companies (or even a single firm) could dominate. It’s not clear which of the current entrants will emerge as the IBM or Microsoft of the clinical trial industry.

But it could also play out differently. With a level of customization that makes each EDC trial a consulting exercise, the life sciences could support a flourishing of more services and technology firms if leading names can’t ramp up their technology or service to the necessary level. That appears to be why Clinipace is doing so well.

The small company in Research Triangle Park, North Carolina has one of the more flexible platforms we’ve seen. It combines data collection (EDC), clinical data management, and study management.

Clinipace’s CEO, Jeff Williams, says a top 5 pharma is using his system. Perhaps half his customers are academic (Duke and Washington University), half in industry (Banyan Biomarkers and Medical Carbon Research Institute).  This page on the company’s website has a list of news releases.

Easy As Pie

How did Clinipace win such endorsements? “It was primarily because of the ease of use of our platform,” Williams says. “The simplicity of it for the end user is really key. There are no extraneous tabs or buttons or things they shouldn’t use.”

Cost also helps. As with all EDC projects, the complexity and duration mean that a typical budget can be tricky to estimate. But Clinipace might be able to do a two-year study for less than $100,000—a significant savings compared to some of the names in the industry.

Full Toolbox

This does not mean the Clinipace platform, which is called Tempo, is minimalist. It has functionality that many larger, more well-known EDC systems lack. And one unifying user interface. Says Williams: “Every aspect of our offering is within a single platform.” With a single sign-on for all its subsystems, Tempo has something that other vendors are still aiming at.

By way of example, the system can collect patient-reported outcome (PRO) data over the internet, using a browser, without a handheld or paper diary. Another advantage: a built-in randomization engine that supports all the major algorithms.

Clinipace makes lab data especially easy to load automatically. The system tracks lab samples, eliminating the need for calls to confirm that a particular sample has reached a particular location. Using Tempo, you can monitor samples on the web, just like overnight shipments. “The site knows that it’s OK and they don’t need to call the patient for another sample,” says Williams. “It sounds trivial, but it’s extremely important to the study.”

Work Flow Wizard

Williams says that minimizing the pain and suffering of the clinical site is one of the company’s highest priorities. “Sites are being hammered,” he says. “[Trials] are not profitable ventures for the sites. The sites are getting better at managing the business.” Clinipace’s assumption is that a site will have zero IT support. As a result, training should be extremely brief.

For all the lip service to the importance of process, Clinipace seems to mean it, with a more malleable system that allows the requirements or standard operating procedures (SOP) of any client to drive the setup of the EDC study.

The company’s Chris Porter, VP of operations and business development, demonstrated the Tempo software for us. He explained there are two inter-related processes that the firm seeks to understand with every engagement: data management and project management. Full-blown clinical trial management systems (CTMS) are overkill for small- and mid-sized customers, but such folks want more than just EDC.

“The middle market is responding well to a product that meets their specific need and does not require them to buy more than they need,” says Porter, noting data can be organized by patient visit or by the functional role of the person who needs to review it. “Customers are getting exactly what they need in a specific way for the protocol. We have incredible flexibility in how we organize the data. It is very specific and tailorable to the project.”

Aiming for Simplicity

Porter says the company assiduously tries to keep data-entry screens uncluttered, even to the point of stripping the “back” button from the browser. “The temptation we have to fight is making this thing ‘cool,’ making it feature-rich, to the detriment of the end user and sacrificing the simplicity,” says Porter.

In a review of the system’s inventory management functionality, used to handle drug supplies, Porter concedes that the system is not a full-featured inventory management system. But it tracks enough for most customers. “Do you need an inventory management system to run a trial?” he asks. “Most likely, no.”

Labs, Integrated

Heather Bristol, Clinipace’s director of project management, demonstrated some of the system’s ability to handle lab data and randomization, depending on the requirements of the study. Says Bristol: “We’re not fitting them into a slot. We’re configuring our software to meet their specified study requirements.”

”The lab samples are logged directly into the EDC system,” she said. “There is no manual entry of the lab results.” The system clearly shows that a particular sample has been logged in.” This has helped sites identify samples that go astray, says Bristol.

Gentlemen, Count Your Engines

The Tempo EDC system, like those of Medidata and Nextrials, has built-in clinical data management (CDM) functionality that many large pharmaceutical companies historically purchased separately. We can’t help wondering if having two engines (EDC and CDM) under one hood is more efficient than welding the bumpers of two trucks together.

Obviously, some big sponsors are happy with a two-truck approach. But Clinipace says a single adequately powered vehicle serves its customers. “None of our clients are using any kind of a CDM,” says Williams. “Our system is managing all of their needs.”