Target Health's president Jules Mitchel has been having a great year. His small, New York-based contract research organization has been posting some numbers that far larger contract research firms would be very happy with.
“We have three approvals with EDC this year already,” Mitchel notes, referring to his customer’s progress in Europe and at the FDA. “We have three approvals with 42 employees. Last year, we had two approvals.”
In his spare time, Mitchel has been a pioneer in developing software for electronic data capture and document management. He may not have the slickest-looking programs, but he remains resolutely proud that they can can get the job done. “We give people what they need. Our system was developed by project managers and data managers, not technology people. We get repeat business all the time.”
Of late, he’s been putting the finishing touches on a clinical trial management system (CTMS). The system doesn’t yet have a module to handle payments to sites. But it does the other work of a CTMS, helping to pick and manage sites. It handles drug supplies. There is a way to help institutional review boards and manage the personnel assigned to a trial. Says Mitchel: “The sponsors should control the data, the software, themselves. The documents and the CTMS should be controlled by the sponsors.”
It is not a matter of national security that Mitchel is an older guy. There are some years under his belt. But he retains the enthusiasm, a joie de vivre, that some much younger people let go off as the decades pass.
And on the topic of his CTMS, he is energized about the reports the system can produce, believing they are powerful enough to help projects run more smoothly. “This is across all studies,” he notes. “I can see all my deliverables.” Demonstrating the system for a reporter, he types in a name, and sees all of the work that that soul owes the trial. “We want to make everything transparent. We don't have to spend a lot of time telling you what's due when.”
The P Word
There are people in the industry who accommodate paper, indulge attachments, and generally don’t want to nudge the clinical trial fraternity toward an age of greater efficiency.
For reasons we’ve never quite understood, Mitchel’s optimism extends toward pushing his own company and clients toward no paper. He doesn't view this as a quixotic quest. He sees it as a matter of efficiency and getting therapies to market as rapidly as possible. “Our goal is to eliminate email and spreadsheets and all that stuff,” he says.
Target Health is paperless, an achievement that is probably only possible at a small firm. Adds Mitchel: “We have no trial master file binders in the company. Everything is on the world wide web in Target Document. We sign everything electronically. We don't have to transfer documents back and forth.”
As a CTMS, his system doesn’t include an audit trail per se. (His EDC system does possess one, of course.) But the CTMS system does have a snapshot feature, allowing a sponsor firm to capture where a trial was on, say, October 31, and be able to use the associated data for planning or strategizing.
The company’s approach, he says, has now attracted a few other contract research organizations (CROs) that realize they need good tools, too. They're using Target Healths' software. “Our business model is to partner,” he says. “We are partnering with several CROs. They may get projects they wouldn't get without it.”
In a separate initiative, Mitchel is exploring ways to connect clinical trials to electronic health records. He is not alone in this regard. But he believes the technical aspects of such linkages may be easier than much of the industry suspects.
One of the most delicate issues is that the integrity of the clinical trial system has to be maintained, as the EHR industry remains unconcerned with the regulations around clinical trials. “The EHR companies claim they don't want to be part 11 compliant,” he says. “So we are populating the EHR as opposed to having the EHR sending data to the EDC company.”
Editor's note: There is another article on Target Health here.d9A2t49mkex