ProTrials Research is a boutique contract research organization (CRO) that Jodi Andrews and Inger Arum founded in 1996. Both of them are still running the Mountain View, California, operation together, with Andrews as CEO and Arum as president. A certified women-owned business with 110 employees and contractors, the company is also certified to be ecologically “green.” One element of that is having converted its invoices to an electronic system.

ProTrials may be small, but it prides itself on taking on complex trials, like a post-9/11 smallpox study or a Phase III HIV vaccine trial with 100 sites and 5,000 patients. “We were the first CRO to monitor and manage an HIV vaccine that went into Phase III in the U.S.,” says Andrews. “It was a very cutting edge program. There was a lot of government involvement. It was not an easy project. There were recruitment issues. We were quite proud of being involved in that.”

More Experience

How has Andrews retained her employees? By setting a goal that no one should have to travel more than 70 percent of the time.

“We are very sensitive to travel,” Andrews says. “People have to do it. But we try to keep it as a manageable percentage. When people feel they have no personal life, that’s when they tend to leave. Our people are our product. They are our most important asset. We try to make sure our employees are happy and challenged. We really do care. It’s not just something I say. We mean it.”

Andrews also takes pains to say that from the firm’s early days, she wanted high levels of expertise in her clinical research associates (CRA), who have an average of ten years of experience in the industry. She’s been able to hew to that view ever since, and it seems to have paid off.

Says Andrews: “One of our goals was to focus on experienced people. We felt that was something we wanted to do differently. We do have a very senior level group of CRAs on board. They are very solid CRAs. They know how to navigate the issues. That sets us apart from some of the other CROs out there.”

Rescue Me

At times, such expertise allows ProTrials to take on trials that have been fumbled by others. Says Andrews: “We’ve been called in quite a bit to pick up from a larger CRO. The No. 1 issue that we come across is the quality of the monitoring and the ownership of the monitors in the field. It’s poor quality or the CRAs don’t know what they’ve missed. They don’t get it. They should have been doing X, Y & Z and they never did. Or they are on so many projects that sponsors can’t get enough of the CRA’s time.”

At ProTrials, she reports, the goal is to have each CRA on one or two projects. Period. “That allows them to focus,” she says, adding that being on 8, 10 or 15 projects is not uncommon at some firms in the industry.

Quality, Not Quantity

Focusing on quality has meant that she has occasionally turned away studies. “I would rather say I cannot do it up to my standards and do it well, than take it on and not do a good job,” she says. “Our business plan is quality, not quantity.”

ProTrials recently cemented a preferred provider relationship with Nextrials, an electronic data capture (EDC) firm. (Both are in the San Francisco area.) “When I have a client that wants to use EDC, Nextrials is the first vendor we propose,” says Andrews. “We have worked with other EDC companies and still do, but we recommend Nextrials. Their system is easy to use. Some systems aren’t.”

Page Turns

Andrews says that the speed of all the major EDC systems has improved. But the issue of the responsiveness of the systems has not completely disappeared, she says. “There is nothing that frustrates a CRA more than to have to wait a couple of minutes for a new page to come up. Speed is really important.” The user interface also matters. Says Andrews: “If the coordinators can’t figure it out, they are not as likely to use it. If it is really difficult to resolve a query, or only one person can resolve a query, that makes it more difficult for the CRA.”

Andrews says the industry still uses prodigious quantities of paper, but that the change in the past five years has been momentous. “We’ve really seen a shift. EDC is now considered more of the norm, it’s more user friendly. Cost has come down. It is comparable to paper.”

One strategic issue for the firm is how to expand abroad as rapidly as her large, publicly traded CRO competitors. Andrews says that global projects typically involve finding a partner overseas to help with the work outside of the U.S. Says Andrews: “We have to find a way to compete in that market as a small CRO. We offer a great service. We’re reasonably priced. We have to convince clients to let us bring partners in.”