One man's middle of nowhere is another man's perfectly situated. That's the way Paul Bishop and Lyle Camblos see Staunton, the small Virginia town that's home to their contract research organization (CRO), Atlantic Research Group (ARG).
“It's equidistant from Rockville and RTP,” says Camblos, speaking of the myriad biotech companies along the I-270 corridor in Rockville, Md., and the many life sciences firms doing business in Research Triangle Park, N.C. Each of those research hubs is about a two-and-a-half-hour drive away. Both Bishop and Camblos—Atlantic's co-founders and its two managing partners—are natives of Charlottesville, home of the University of Virginia, under an hour away.
ARG (tag line: “Trials without Tribulations”) was born in 2005, after both men quit their jobs at PRA International (Bishop was in functional management; Camblos in project management) and then let their non-compete agreements expire. Their time in the industry (Bishop at PPD, Cato Research; Camblos at Inc Research) had left both men with the strong impression that small and medium biotechs and pharmas were not always happy when outsourcing trials to big CROs.
“A lot of them had poor experiences with larger CROs,” says Camblos. “Service wasn't ideal. Often their project wasn't the largest priority.”
There was a hole in the market. When he and Bishop launched ARG, their goal became to cater to that sector, and to be extremely service-focused and comprehensive. A few months after launching, says Camblos, they realized that a robust clinical trial management system (CTMS) was going to need to be the cornerstone of what they offered. They hired Hunter Walker, also formerly of PRA, as ARG's vice president of clinical systems. Walker, who is in San Diego, designed TrialVista Clinical Systems, ARG's web-based, customizable CTMS, which is free to clients and sold individually.
Bishop says this sets Atlantic apart from just about everybody. “What differentiates us from any other small CRO is we have a strong technological component, a CTMS that companies can buy even if they don't use ARG as their CRO.” Why was a strong service-oriented CTMS so badly needed? Says Bishop, during many of the trials he was involved with prior to launching ARG, even if a large CTMS was being used, many of the people conducting the trial were furtively squirreling away Excel spreadsheets and keeping their data outside the larger system. (We recently examined another approach to turning the industry away from spreadsheets here.)
“They'd say, 'The system is not easy to use. It's bulky and inflexible, so we're keeping Excel spreadsheets on the side and tracking things that way,'” says Bishop. “That is not the best way to manage trials. It's not a seamless integration. They weren't using systems to their full potential.”
Bishop and Camblos have tried to make TrialVista highly user friendly, and have attempted to use every possible step of a trial—and automate it. “It's start to close-out, taking over any and all tasks previously handled manually—by email, fax, phone, spread sheet,” says Camblos, adding that the system is a living thing. “It's been constantly developed over two and a half years, and development continues on it. Every month or so we tweak it, and come up with new features. That's the nice thing about it being web-based.”
And, he says, it's agile. The time to get it up and running is days, not months. Cost savings come through saving time. For one recent client, ARG was able to get the first patient enrolled only six weeks after signing the contract. “That's something I'd never seen in my previous life, and I don't know if we'd even have been able to do it without a system like TrialVista, that allows you to track and follow the work flow of getting sites up and operational without missing anything, and as quickly as possible,” says Camblos.
Another unique feature of their system: patients use it, too. It's permissions-based, with each party—patient, investigator, CRO, sponsor—seeing only what is pertinent to them. “In our previous experience, we've never seen the inclusion of patients in a system,” says Bishop.
Enrollment is a key area in the industry that needed help. Explains Camblos, well before getting involved in a study that uses TrialVista, sites fill out an online questionnaire so the system can identify the right sites for the study and work with only those. From there, the system helps zero in on problems at the sites.
“Studies always get delayed or derailed because of enrollment issues,” Bishop says. “The system can track which patients are not being screened, or if they are being screened, why they have failed. It allows us to track enrollment fluctuations faster, in real time, so the sponsor can make a quick decision: do they need to make a change? Add more sites or different sites? Make a protocol amendment?” With many CROs, most of this type of communication—from what Bishop and Camblos saw—was done by fax, and thus very slow and inefficient.
TrialVista has not yet been called upon to interact with electronic data capture (EDC) systems; no clients have requested that. But it's ready, using application programming interfaces (APIs), says Camblos, adding that ARG has had discussions with Perceptive about connecting to its EDC system.
Help Desk Indeed
TrialVista has a 24/7 help desk, which is sometimes staffed by Walker himself, TrialVista's creator, a perk of choosing a small company. To buy the system, there is a set-up cost, and then it's priced by user fees. So far, there are a handful of companies doing that, in the U.S., Europe and Russia, says Bishop. Talk of the system had mostly spread by word of mouth, until last year when ARG developed a formal marketing plan to get the word out.
ARG now has 20 employees, most of which are in Staunton but a few of whom are in a satellite office in San Diego. Monitors are regionally based. The CRO's therapeutic areas include oncology, immunology, cardiovascular, ophthalmology, metabolic disease and nephrology. ARG has worked on 18 trials in its four years. Bishop and Camblos say they expect 15 to 20 percent growth in staff and revenue this year.
So far, both say they are very happy in their sector of the market, and they don't feel the competition from the big CROs, nor do they plan to jockey for business from big biotechs or big pharma. “It's just not our niche,” says Camblos. “It's not what we do.”
Meantime, development of TrialVista continues, based on what's not working in other CTMS's. “Hunter goes to many conferences, listens to what people say is lacking in other systems," says Bishop. "On a nearly daily basis, he's finding something that we test out to make our system better.”
—by Suz Redfearnd9A2t49mkex