The three founders of Integrium didn’t set out to start a contract research organization (CRO). It just ... happened.

It was the mid-1990s. David Smith, Joel Neutel and Michael Weber were southern California-based clinical investigators. In the course of conducting their research at the Long Beach Veterans Affairs Medical Center, they were being asked by pharmaceutical companies to do much more than that. Write protocols. Find other investigators. Produce articles. It went on and on.

“Soon, they realized they were looking like, smelling like and acting like a CRO, so in 1998 they created one,” said Richard Coroddo, Integrium’s director of business development.

Sharp Focus

Since two of the three doctor-founders focused on cardiovascular disease (Weber is a nephrologist), they tailored their CRO to do the same. Along with hypertension work. And metabolic studies. Focusing on just those therapeutic areas has not limited the company at all. In fact, says Coroddo, Integrium has all the work it can shake a stick at.

“[Cardiovascular] is a big piece of the pie as far as clinical development goes,” he says. “There’s a lot of money being spent. We’re very busy keeping up with demand, and it will be an area that will continue to grow.”

Clients Of All Sizes

That, says Coroddo, is due in part to demographics—think Baby Boomers—and to so many new products aimed at cardiovascular ailments these days. “Device-based approaches to heart failure, drug-coated stents, the use of lasers,” Coroddo says, naming a few.

As is typical for a therapeutically based CRO, Integrium focuses not just on drug development, but rather on the three Ds: Drugs, diagostics and devices. And the company works with a mix of pharma, big and small, and biotech, big and small.

Headquartered in Tustin, Ca., in Orange County, Integrium opened offices in Bedminster, N.J., and Johannesburg, South Africa, three years ago. Two of the company’s founders (Neutel and Smith) hail from South Africa.

Integrium’s employees number 120. Smith serves as chief medical officer; Neutel, who also runs a research clinic in Orange County, is a consulting physician; and Weber has moved on to other projects. He’s now dean of research at SUNY Downstate in Brooklyn.

Extended Timelines

In Integrium’s nine years, it has done about 100 trials. Coroddo said that cardiovascular studies can be big, long and intense, which ends up limiting the amount the CRO can do. Or at least do well.

“Many of the studies are long-term, like five years,” he said. “Plus, rather than taking all the work that comes our way, Integrium likes to focus in on a few important trials. We try to have a well-managed project load.”

Competition in the space is limited; Integrium is one of a small handful of full-service clinical development cardiovascular-focused CROs. One thing that makes it stand out from that tiny pack, says Coroddo, is its investigator database. Integrium keeps very detailed profile information on each site they’ve worked with. How well did they enroll? What was their screen failure rate? Their query rate? How well did Integrium staff like working with that particular investigator?

A Good PI List

“A lot of CROs will just have a long list with the investigators’ names and addresses,” says Coroddo. “We tend to be much more detailed about the level of info we track.” Which, in turn, helps them choose very wisely for sponsors, he says.

As for electronic data capture (EDC), about a year ago, Integrium began using the branded offering of another CRO, ClinPro’s ClinPlus.

International Growth?

Thus far, the company has not been involved in any acquisitions or mergers. “Just organic growth, slow and steady,” says Coroddo.

To keep up with demand for trials in other countries, Integrium has partnered with other CROs that have a presence in places like South America and Europe, but no mergers are on the agenda. Instead, the company is planning to expand. Where? They’re not sure. Yet.

“We’re looking at where we want to go. We haven’t yet pulled the trigger. But it will happen within 12 to 18 months,” says Coroddo.

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