In 2007, Montpelier, Vermont’s Green Mountain Logic has announced it would integrate its LabPas CT laboratory management software with no fewer than five electronic data capture vendors (ClinPhone, etrials, Omnicomm Systems, Phase Forward, and Phoenix Data Systems).

To find out why Green Mountain Logic is on a roll, we rang up president and CEO John Rosenblum. He explained that while the company is a software concern, its main focus is in broadly helping Phase I clinical sites. “We are very clinic-oriented as opposed to sponsor-oriented,” says Rosenblum. “LabPas automates the day-to-day operation of Phase I trial. The market is clearly clicking.”

The company’s focus is not trial-by-trial, as with later-phase research; that would provide few efficiency gains. Rather, Green Mountain Logic worries about the totality of what a Phase I site does; its products make those activities run more smoothly.

‘Like A Ballet’

The heart of the LabPasCT package for clinical trials helps correctly bar-code and label laboratory samples—and schedule the work load. Coordinating a bioequivalence study with blood draws on 50 subjects unfolding precisely every fifteen minutes, he says, is a complex undertaking. The scheduling is intricate, bordering on the elegant when it’s done right. “It’s incredible, almost like a ballet or a dance,” says Rosenblum.

From the sponsor community, he says, there’s rising pressure to see all of the latest lab data from Phase I facilities even when it must be manually collected. In some cases, such sites have barely finished drawing blood for one project when they get a fax requesting the vital signs for another.

CRO Adoption

The interfaces with some key EDC vendors can halt that volley of faxing, allowing the sponsor or contract research organization (CRO) to see the data almost immediately. “We edit check the data on the way in real time and transfer that data to the EDC company in real time,” says Rosenblum.

He predicts that CRO industry usage of Phase I automation software will become a competitive issue within two years. “By 2009,” says Rosenblum, “the CROs that aren’t automated will be at a significant disadvantage. Any CRO that is automated will outsell those that aren’t, with faster data lock and fewer queries.” Typically, he says, software can strip out 80 percent of queries that would occur because of manual processes or human error.

He does not believe this is a bad thing for the CRO industry. On the contrary, he reminds us about the automated teller machine, and of the services that now come with it. Similarly, he says, the CRO industry probably cannot foresee what more real-time data might allow it to do. Adaptive and flexible trial designs, even go/no-go decisions might be accelerated with better access to lab data, he speculates. Says Rosenblum: “What we want is one data set that follows the compound all the way through.”

Larger Efficiencies

Rosenblum predicts that there could also be a geographical shift. Says Rosenblum: “As you consider the pressure of overseas CROs for European and American sites, they are going to have to offer a high-value, high-quality service. They’re not going to compete on price. It’s going to be North American and European sites that are first to automate.”

Unlikely as it may seem, one customer employs someone simply to watch data being manually transferred from one system to another. Such jobs, Rosenblum says, will evaporate.

Increasing Comfort

The LabPas CT product also helps Phase I clinics recruit subjects, facilitating a telephone call script and maintaining an email database. “Our customers will be able to recruit a trial without spending any advertising money,” he says, noting that many are university-based and can rely on messages being informally passed from one willing student to another. It also assists in running a call center. “Our software helps the recruiter determine what trials that person could be screened for,” he says.

Customers, he says, have a rising level of confidence in the permanence and authenticity of electronic lab records. “The biggest change is the acceptance of electronic audit control,” says Rosenblum. “We’ve seen people go from having to have paper backups to completely accepting electronic records for an FDA compliant audit control. Before HIPAA, there was push back.”

Editor’s note: An earlier version of this story had links to the Green Mountain Logic website. Such links stopped working after the company’s October, 2007 acquisition by Phase Forward, and have been removed until we can link to relevant information about Lab Pas CT.