Technology executives in the clinical trial realm often predict consolidation. Translation: smaller companies will die. There are examples of that—CB Technologies or Ninaza. But not dozens.

On the other hand, Target Health is a thriving example of a more complex trend. That would be the blurring of the formerly sharp line between services and software. In other words, between contract research organizations (CRO) and technology vendors. Target Health is both.

Rave Reviews

Its system featured tools to manage documents long before most competitors, as ClinPage wrote a few months ago. In 2007, three customers have filed NDAs using the firm’s technology. At the same time, Target Health is a boutique CRO that prizes the fact that all of its customers are referenceable.

“Using Target Health’s Internet-based clinical trial system, Target e*CRF, we are able to monitor device safety in real-time in a high-risk neonates undergoing cardiac surgery. It’s nice to know the status of patient enrollment and data entry without having to contact the clinical study sites directly,” says Eli Pines, VP and chief scientific officer, Synthemed.

“With Target e*CRF, we have been able to keep completely informed of the study status anywhere in the U.S. and were able to do a key interim analysis within two days of the final patient measurement,” says Sam Lynch, president, Biomimetic Therapeutics.

Tech, Services Hybrid

“We have been able to view site activities (data entry, queries, audits) in real time and save a great deal of time and money through our ability to quickly lock a data base and perform interim analyses when necessary.  With Target Document, we have been able to seamlessly manage documents, in a cost-effective way, for a worldwide trial in pediatrics, without the need of multiple paper copying, email and overnight express carriers,” says Benjamin Levinson, former VP of drug development at Wellspring Pharmaceutical.

Those are impressive endorsements. “It’s about know-how and service,” says Jules Mitchell, the company’s president and an erudite observer of the industry who worked in big pharma before starting his own firm. “You have to manage the expectations.”

CRO Collaboration

When we pointed out that he is competing with companies that (on the CRO side) have tens of thousands of employees or (on the technology side) a hundred million bucks in revenue, Mitchell was unfazed. “The fat lady hasn’t sung yet,” he says. “There’s a lot of opportunity.”

Target Health bids jointly on projects with CROs, he notes, and has always done so by knowing where it can shine and where its partner will perform well. “We work with them on projects,” says Mitchell. “We never feel threatened. I don’t think they feel threatened. The sizes are very different. The strengths are very different.”

Simple Systems

His is the rare CRO that has its very own electronic data capture (EDC) solution, the aformentioned Target e*CRF. Some academic sites that have used it at sponsor’s behest, Mitchell reports, later ask to purchase it for themselves. But he doesn’t see technology as a panacea.

Says Mitchell: “You still need to have processes in place and run a good clinical trial. [Technology] may facilitate and reduce errors. But if it’s not a user-friendly system, or it’s difficult to make changes, it will hurt your program rather than help it.”

No Bloat

Mitchell thinks some EDC systems have become unwieldy. He’s an advocate of simplicity. Says Mitchell: “Let’s get the data into the system, manage the data properly, get the audit trail done, and analyze it in SAS. If you focus on that, and make the clinical sites happy, you win. If you try to make everyone in clinical research happy, you run the risk of an enormous amount of training and three months to set up the study.”

Cost is important, too. “We try to make it more cost effective,” says Mitchell. “We are never more expensive than paper, and usually a lot less.” Growth is happening, with the company needing another floor in its Manhattan suite to handle new employees.

Oracle Vet

One of them is a new VP of business development, Adrian Pencak. He notes the company’s EDC software is the only commercial package developed internally by a CRO for its own use. “It blends our expertise and technology in a seamless way,” says Pencak. “We took the sites as the number one priority. The poor sites. They are beaten up by sponsors. With our tool, we made it simple. You only see what you have to do.”

Pencak helped to build the Oracle Clinical franchise. (It’s striking how many people we’ve met in the past year who formerly worked at Oracle.) Pencak says few other companies in the industry can boast, as his can, of having completed 100 studies. Few systems allow a second trial to be started on the basis of a first with just a few mouse clicks. In some cases, that can get done in one day. “Our worst case is four weeks,” he says.

Batch Edit Checks

Pencak cites other well-liked features. Batch edit checks can use standard SAS programs and can be run at any time within Target e*CRF. That eliminates the need for data management to communicate offline with the clinical research associate (CRA) to resolve the batch edit checks. It also reduces the time to resolve the more complex edit checks and puts all edit checks inside one system. Monitors can review and address the edit checks as long as they have access to the Internet.

A simpler system means it’s easier (and cheaper) to make changes. “We talk about hours or days to make changes as opposed to weeks or months,” he says. Some of the efficiencies are being passed on to Target Health’s CRO partners, Pencak says: “We can increase their margins significantly.”

Frustration In Market

Pencak notes that the company’s expertise has given it the confidence to push back when a sponsor wants to do something that might not be in the interest of system performance or the site’s user experience. “Do you need an alert for every occasion? What kind of overhead does that add to your audit trail?” he asks. “We take a consultative approach when it comes to running EDC studies.”

Pencak, like Mitchell, sees plenty of opportunity in the EDC space and in helping clients with traditional CRO tasks like medical writing and regulatory affairs. One factor: a residue of frustration about past promises made for EDC. Says Pencak: “People are not gaining the cost savings they envisioned going to EDC. It’s is taking them 6 months to build the study. Things they envisioned—that whole perfect world—they are not seeing.”

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