Christine Pierre, president of the investigator site group and consultancy RxTrials, shocked parts of the industry this month when she hired Adam Chasse away from global CRO Quintiles and Dan Milam from Sanofi Pasteur, the largest company in the world devoted to vaccines.

Chasse, who had been with Quintiles since 1995, had most recently been head of the CRO’s Prime Sites program, helping Quintiles establish and maintain relationships with specific, high-performing academic medical institutions and hospitals around the world. Milam, with Sanofi Pasteur since 2002, had been a regional clinical trials manager for the drug developer.

And both left to join a site network? Yes, and for that both are getting furrowed brows and questioning looks from colleagues.

“The feeling is that the pinnacle is to make it to pharma, so why would you go back?” said Milam. “This is unprecedented as far as I have seen.”

But the industry is changing, consolidation is here and both men, who have worked extensively with investigator sites on behalf of their previous employers, said they felt they had a lot to bring to the site side of the industry, where clinical research actually takes place and where many of the research process’s stumbling blocks reside. And they’ll be able to help sites see from the other perspectives.

“What my new colleague and I bring are more of a sponsor- and CRO-eye view of what’s expected for a site network,” said Chasse, who will stay in the Research Triangle area and serve as RxTrials’ vice president of business development from there instead of relocating to company headquarters in Maryland.

Milam joins RxTrials as executive director of clinical operations. RxTrials has 10 sites in five states under its umbrella and also runs a consulting arm that helps sites revamp their business operations. Milam and Chasse will be involved in both parts of the business.

Also joining the business development staff is Rebecca Little, who worked on the development team at the Mt. Pleasant, S.C.-based site group Elite Research Network. She will stay in South Carolina.

Chasse said it’s an exciting time to roll up one’s sleeves and help beef up operations at the site level. “The focus on site performance is no longer just coming from the traditional customers—sponsors and CROs,” he said. “Regulators are also now paying a lot of attention to sites. It’s an exciting space to be in to make a difference and try to please all those entities. RxTrials is poised to very directly make a difference.”

Said Pierre, “[Chasse] will help us think more strategically while we look at our opportunities both locally and globally. We want to be more strategic, not just in where we’ll be today or tomorrow, but in where we’ll be in five years.”

Is a big expansion of the network afoot? Not necessarily, said Milam. “We want to best meet the market needs, which are changing. You have to get a little more savvy and creative in your business development, and it’s not all about getting bigger.”

Added Pierre, “We think adding too many sites or adding sites too quickly can implode a really good research network. For now, we’re looking to grow some of our current sites.”

The intense focus on improving site operations makes sense, said John Kreger, a financial analyst with William Blair who has been scrutinizing the clinical research outsourcing space for almost 20 years. He said studies show trial delays are more often than not caused by enrollment problems, which are considered site issues. “The thought is that if we improve efficiency at the sites, we could add a lot of value,” he said.

In this era of seismic shifts in the industry, consolidation and unexpected partnerships, is anything else in the works besides enhancing operations at the network’s 10 sites and helping sites that use RxTrials’ consulting services? Maybe.

Said Chasse, “We think we have a lot to offer sites in a variety of different ways, some of which are defined and some of which we are still defining. I think what we’re doing will evolve over time.”

--Suz Redfearn