It's a great debate, and far from over. Some analysts predict the large contract research organizations (CRO) will eventually manage the bulk of industry-sponsored research. Others predict that mid-tier and specialty CROs will command a greater share of clinical trials as the giants struggle to take care of small customers as well as they pamper megaclients. Or maybe it’s both, says Susan Bornstein, executive VP at the Eliassen Group.

She predicts that both large and small CROs will prosper. Massachusetts-based Eliassen has a division called eClinical Solutions that focuses on end-to-end data management, EDC implementations, technical consulting and training services.

Bornstein says many sponsor companies appropriately seek out a therapeutically specialized firm. “The biopharma companies should go with a clinical CRO that specializes in their therapeutic area,” she says. The company's approach is to ensure a strategic understanding of the value of clinical data. “We don't want data to be an afterthought,” Bornstein says.

Better Business Climate

The pace of the research business, she reports, is quickening. That will continue into the next two years. Says Bornstein: “It seems like the industry is still being conservative on the volume of trials they're running. Trial volume will pick up somewhat next year and then a bigger increase in 2012.”

The eClinical Solutions group is specialized, she says. “We only do data management and SAS programming, the back end,” she notes. “We look for companies that want to do that best of breed approach.”

In many cases, she says, the firm's customers support the Clinical Data Interchange Standards Consortium (CDISC) data guidelines, but not to the letter. “Most of our clients call it STDM plus-minus. It is mainly that, and they tweak it a little,” she says. “We do a lot around data mapping and legacy programming,” converting old data to newer formats.

One Place

She says one draw for her customers is a clinical data repository (CDR). “It is a very affordable entry,” she notes, with perhaps 30 percent savings in comparison to CDR offerings from Oracle and SAS. “We offer a CDR that is more affordable for the mid-market. They can have all their data in one place.”

Some decisions to acquire CDRs, she says, are being made in a context of a more assertive FDA. As agency officials ask sponsors more questions about the data, the sponsors are finding that a repository can be helpful, providing visibility across multiple projects and other benefits.

Government representatives, she says, “are asking more and more questions and getting involved in fraud detection and data quality. Clients are looking to interact with their data and manage their data proactively.”

Change Management

She’s polite about it, but she says that one of the reasons that the usage of EDC hasn’t resulted in significantly shorter or cheaper trials is that the technology was simply slathered on top of existing, paper-based processes. “You can't just take those paper processes and run EDC," Bornstein says. "They didn't change how they work. If you change how you work, there will be savings. It's more in cleaner data, sooner.”

What’s on the horizon? The industry will be tying its existing clinical trial systems into the electronic health record (EHR) systems used by physicians and hospitals. But it will not be easy. Still, she says, it’s starting to happen, and not just glitzy demonstrations at trade shows. Bornstein says: “There have been actual pilot studies done. We are seeing some movement in that area.”

As with other observers of the trial-EHR linkage, she says there are profound questions to be worked out. “Who owns the data? Which is the source? Does it move in both directions or one direction?”