In a collegial industry, all clinical trial suppliers must work intimately with rivals. No matter how large or small a competitor may be, professionalism requires putting aside emotions of wariness or distrust. It's hard enough to get the science right, obey the law and finish the study.

But tensions between large and small firms are rising in today's tenuous economy. At some sponsors, project launch decisions are embedded in amber. In such a climate, large contract research organizations (CROs) are struggling to sustain a steady volume of projects. Just to close a deal, large CROs may offer to handle one element of a project gratis. The dangers of collaboration are more acute for smaller clinical trial specialists. For them, losing a single major client could be a mortal wound.

Dynamic Team Selection

Such are the intricacies that absorb Michael Harte, founder and president of The Harte Group. The Harte Group is his hand-picked network of functional service providers (FSP) that toil in the shadows of large CROs. Citing unpublished research, Harte says the usage of FSP providers is up 44 percent, according to a survey of more than 300 sponsors. The industry likes the flexibility of FSPs.

Smaller FSPs, according to Harte, typically need marketing and networking assistance. "Most of these guys, nobody knows who they are," Harte says. That's where he comes in, serving as a director of business development for firms under his umbrella. To avoid delay, sponsors signing on with Harte can get custom-selected teams of multiple FSPs. He's currently working with 73 FSPs that collectively have more than 10,000 employees.

Despite appearances, he says, smaller firms in the industry bring more seasoned expertise to the table than big ones. In trying to land business, smaller FSPs don't have one team to dazzle prospective clients with, and another group of folks who actually do the work. Many sponsors, let's face it, are impressed by the razzle-dazzle team from a big CRO even if they never encounter it again.

One Price, Contract

Harte's role is similar to what general contractors do in home construction. Harte's vetted companies include FSPs that handle biometrics, monitoring, biostats, safety, technology, regulatory affairs, medical writing, NDA submissions and data management. One of his recent projects had 11 different subcontractors.

The smaller size of his projects means that he can offer extreme agility, pulling an experienced team together in hours, not weeks or months. "On a dime, we can go and pull a team together," Harte says. He does not charge to belong to his network, only when live deals or projects start. For sponsors, he says he can improve on the baroque request for information (RFI) process, bringing together a team that is perfectly matched to the trial at hand. If sponsors have a particularly beloved supplier in one niche, that's fine.

Harte cites another industry survey that showed considerable dissatisfaction with the pricing and service levels of traditional CROs, and believes he can offer a better model. One reason? A single fixed price contract that covers all the FSPs a sponsor needs on a trial. That radically simplifies the process of finding and hiring umpteen different suppliers.

'We Police It'

Another part of the appeal, according to Harte, is that the FSPs in his network have agreed to standardize around key processes and technologies (one of them being Microsoft Sharepoint) prior to the start of the trial. That ensures the trial data flow to a portal that everyone can see, allowing glitches to be resolved quickly.

So while there will always be trial-specific details to hammer out, some of the preparatory electronic and human linkages between different FSP organizations already exist. "I am doing something completely different," says Harte. "There is accountability, there is ownership, there is experience. We set up a management and reporting element. We police it. We set up the financial aspects to govern the execution. You are getting very seasoned, experienced individuals."


Michael Harte

Finally, he says, his project managers have more autonomy and authority than is typically the case in full-service CROs. His project managers will be able to resolve issues expeditiously without getting into a protracted bureaucratic dance with senior managers, lawyers and human resources personnel.

Should a provider not perform as stipulated, Harte notes, the rules of the network allow for a new provider to be swapped in. Needless to say, the lackluster performer is axed. That creates an incentive for performance (for suppliers) and peace of mind (for sponsors).

Old Pros

Harte says there may be a unified psychological profile to the companies in his network. These people are not just starting out in the industry. They have not been anesthetized inside the well-padded walls of large corporate bureaucracies. They have not lost the verve of their early years. Indeed, they continue to love clinical trials. They just might not want to spend all their waking hours wading through five or six layers of management.

"These people want to practice their craft," Harte says. "They enjoy science and the work they do. They do it well. If you go to a full service provider, these are the people as part of a pitch team. But generally, they are not the people doing the hands-on work." In essence, Harte says, the smaller FSPs are entrepreneurial refugees from large CROs and sponsor firms. If they're working for Harte, they might have twenty years of experience—not two.

Technology is not an afterthought to how Harte's projects unfold. He's a former sales guy and top executive at etrials, which was acquired by Merge Healthcare. Says Harte: "Without technology, you are waiting on paper, you're waiting on process. Technology allows the changes to happen."

Here's an earlier article on Harte, who will be speaking at several industry conferences this year.