Saratoga, N.Y.-based contract research organization (CRO) Criterium is planning to open an office in Toronto. The move was client-driven and will be where the company’s newly appointed director of global affairs, Lawrence Reiter, Ph.D., is based.

Reiter has worked for Criterium since 2003 and was formerly managing director. All global operations will report into Reiter. He will also be responsible for ensuring that operations in new offices that Criterium opens are standardized.

“We have a new position at the company called director of global affairs. What that means is that for the rest of the world, everything needs to be coordinated, everything codified for every office because we will continue to open offices. [Dr. Reiter] is one of the folks who have been with us for some time, and he’s coming to North America from overseas so that he’ll be in our time zone,” John Hudak, founder and chief executive officer of Criterium, told CWWeekly at IIR’s 17th Annual Partnerships with CROs conference in Las Vegas.

Criterium has three Canadian clients that have studies ongoing in Canada as well as other parts of the world.

Criterium was founded in 1991 and has 117 staff, including full-time equivalent (FTE) and permanent consultant staff. The company began conducting clinical trials globally in 1997. In 2003, the company opened its Johannesburg office; in 2005, it opened offices in Pune, India, and Berghem, The Netherlands; last year, the company opened offices in Boca Raton, Fla., St. Petersburg, Russia, and Gedera, Israel. The company has 21 active clinical trials...

Criterium’s trial management model employs technology flexibility and a centralized workflow process. “Wherever we do work around the world, it’s still the same process,” said Hudak. “The sites, wherever they sit, get the data directly to New York. And once we have them in New York, then we can start to make decisions with them. We process them, we query them and then incorporate them into reports so we can make decisions on the fly about how things are going in Russia and South Africa,” he said.

Criterium also discussed the different paradigm that it has employed for the past five years, requiring a new position to be named recently—clinical data liaison—to reflect that difference. “We really believe it’s a new paradigm. We feel that we’ve broken down the silos, and we have data management now blended very beautifully with what we call our clinical data liaisons, who are in-house monitors who assist the field monitors,” said Ronny Schnel, executive director, business development and client services for Criterium.

“The clinical data liaison in Saratoga is a kind of hybrid of a clinical monitor and data management, so we break down that traditional silo between the clinical team and the data team, and in-house they actually work on both. They’re the first line of data reviewing when it comes to New York directly from the site. They send the queries back directly to the site, then they instruct the monitors in the field which sites to go to and what work has to be done at the sites. So the field monitor goes into a site and knows what to expect. [The field monitor’s] primary job is to do source document checking and troubleshooting at the sites,” said Hudak.

The company plans to open more offices globally wherever sponsors want to conduct clinical trials.

“We went to areas where our sponsors asked us to and where we could have the Criterium style and do it. We’re doing it. In 2007, we were on the runway, and in 2008, we just took off,” Schnel said.