Target Health is not your average contract research organization. In fact, it’s an “e-CRO.” Key to becoming a player in the brave new e-world was Target Health’s development of its own suite of patented software and its championing of the paperless clinical trial. “I was always an independent thinker, but it was not always appreciated within large organizations,” says president and cofounder Jules Mitchel. “No matter where I worked, even in smaller companies, I had a gut feeling I could do it better.”
Mitchel’s pharmaceutical industry experience includes work at Wyeth and Pfizer, as well as a background in research, which has informed his current role. “Basic research allowed me to express my passion for learning and to develop problem-solving and analytical skills, no matter what the problem,” Mitchel says. “It also taught me how to experiment and to appreciate serendipitous findings, and not to be fearful of new knowledge and changing direction once there is an ‘aha’ moment.”
The most important skill Mitchel honed in his early years, however, was patience. “I used to do aging studies that took three years to do,” he says. “Things take time. A lot of people in business are not patient enough, so they make silly decisions.”
Patience came in handy when Target Health was cofounded in 1993 by Mitchel and his wife and CEO, Joyce Hays. “I have an MBA and a PhD and all that stuff, but it’s not the same as the real world of actually running a company,” Mitchel says of the “reality check” involved in guiding a company. In addition to generating business and hiring the right people, Mitchel had to adapt his leadership style. “When you have your own company, you have to balance empathy and concern about your employees, but also demonstrate a level of firmness, and you have to develop that,” Mitchel says. “Not easy.”
Although running a paperless operation wasn’t a foundational imperative for Target Health—“In the beginning we were focused on surviving,” Mitchel says—the idea had been forming on the back burner. Mitchel tried to go “as paperless as possible” while at Pfizer and Wyeth, but at the time, only smaller companies were embracing the movement. At Target Health, it was Hays who pushed for paperless, saying, “We have to do something in the e-world.” Eventually, Mitchel went to a meeting and saw how electronic data capture worked. “I said, ‘We should do this,’ and my wife was very happy that I finally agreed with her.”
Ahead of the curve, Target Health started to go paperless in-house and develop its own software in the late 1990s. “Our first customer is our employees, and if they don’t like the software, we know about it,” Mitchel says, “because they won’t use it, and then we have to fix it.”
The biggest challenge Mitchel has encountered is convincing sponsors to use the technology—getting people to change, to embrace disruptive innovation. Once clients are on board, however, Target Health sees a lot of success. “The sites love it. Everybody thought the sites would be the problem, but the sites are not the problem,” Mitchel says.
One of Target Health’s current projects is with a big pharmaceutical company, serving forty centers and 400 patients. According to Mitchel, enrollment is about two months ahead of schedule, the study is on track to wrap up ahead of schedule, and 95 percent of the data are entered in real time with less than 1 percent database changes. “The biggest problem is that people try to use old processes with the new solutions, and you can’t. You have to rethink the whole process,” Mitchel says. “That’s the most difficult part—getting people to change their behavior.”
Going paperless has revolutionized the clinical-trial process and the health-care industry in general. Target Health estimates that it can save pharmaceutical companies up to $10,000 per site, per year, but more importantly, the ability to see data in real time has the potential to improve quality, and even to save lives. “If you went to the doctor, and you have a disease, and you had to wait a week to find out, but the treatment has to happen in four hours, you can’t wait a week. . . . To be able to see the data in real time and react in real time has revolutionized everything that we do,” Mitchel says. “Now the physicians can see twice as many patients, they’ve told us, because when the patient leaves the clinic, there’s nothing for them to do. All the data are already in the system.”
While some clients do just use Target Health’s software, the company prides itself on offering end-to-end services. “What differentiates us from some of these other techie companies is that we actually execute projects,” Mitchel says. “If someone gave you Microsoft Word, Microsoft doesn’t care what you put into your document, but we actually care; we provide all the services. We have to deliver not just the software, but the product.”
Target Health’s range of services can take a product from pre-clinical to new drug application. According to Mitchel, the most important aspects of getting a drug to market are doing good strategic planning, having experience, and working closely with regulators. “And then educating the clients about the reality of dealing with FDA, since so much is counterintuitive, until you learn the drill,” he adds.
The next challenge that Target Health is tackling is convincing competitors to incorporate its e-source solution into their software. “We have a lot of NIH [not invented here] challenges, although once we finalize the regulatory submissions that are using our software, the business horizon will change,” Mitchel says. Innovation by innovation, Mitchel is patiently gaining ground toward the ultimate goal: becoming the industry standard for the paperless clinical trial.