Palm Beach CRO in West Palm Beach, Fla., may be a new player in the clinical trial industry, but its founders and leadership are not.

The contract research organization (CRO), which opened in December, is an outgrowth of Palm Beach Research Center, a clinical research site headed by CEO David Scott. Although that business is a separate entity from Palm Beach CRO, it provided the funding for the new business and has conducted more than 500 clinical trials and worked with more than 110 pharmaceutical companies in its 15 years of operation.

Palm Beach CRO's executive vice president Arthur Simon, Ph.D., spent 24 years as president and CEO of Research Testing Laboratories, a combination CRO/site management organization in Great Neck, N.Y., before taking over leadership at the new company. Simon's experience and relationships within the industry are key to Palm Beach's new business strategy, Simon said.

"We're very much into delivering certain therapeutic areas with expertise having sites that can get up and running almost immediately. I know everybody says that--it's hard to differentiate yourself--but the experience I have and what I've brought to the table--the speed, the timelines, staying within budget has always been one of my fortes," Simon said.

Palm Beach CRO offers phase II to phase IV clinical trial services and has 10 multicenter trials in the works, three of which are currently enrolling. These studies are located throughout the country and have a minimum of five to 15 sites.

"The size of studies that we do is our niche, as well. We'll do studies that range up to 20 or 30 sites in a study. The largest has been 40 sites," Simon said.

The CRO has 20 full-time employees, mostly based in Florida, and is currently hiring for several positions, Simon said. Palm Beach relies on outsourcing relationships to provide certain services, such as data management and central lab. Simon said many of these outsourcing relationships are with companies that he has known or worked with for at least 15 years, enabling him to ensure that Palm Beach's partners meet the CRO's quality and work standards.

These partnerships also are helping the company branch out internationally.

"We have just formed a very important partnership agreement with Karmic Life Sciences in Mumbai, India," Simon said. "They do a lot of data management and statistical analysis, but they also have clinical capabilities. That's our first entry into the India operation."

Palm Beach is working on placing a diabetes program in India now, and Simon hopes to have sites up and running in India later this year.

"For the last three or four years, I've been very interested in going into India. The China and Southeast Asia connection--I'm not going there. I don't feel comfortable there yet. But we have in India a population for patients. Patients need care, patients are easy to get to enroll, and it's English language," Simon said.

India is just the first planned international expansion for Palm Beach, Simon said. The company plans to branch out into Mexico in the next three years.

"There are maybe three or four of the large players working as CROs down there [in Mexico], but I don't get the feeling that they're doing quite enough. I used to do a lot in Mexico and Mexico City, and now I'm looking over in the Cancun area because of the proximity. We are only an hour and 20 [minute] airtime flight to Cancun and that area," he said.