Oct 17, 2005 | Last month, Phase Forward bought drug safety specialist Lincoln Technologies. This is the most intriguing clinical trial technology deal of the year.
With a price of $11 million, the acquisition demonstrates both Phase Forward’s financial resources and the appeal of Lincoln Technologies’ Java- and Web-based tools for the analysis and visualization of drug safety.
“When we talk about safety, we are willing to put our money and resources where our mouth is,” says Phase Forward president and CEO Robert Weiler. “We are extremely excited about this. It redefines the market requirement for entering into an electronic data capture (EDC) or safety platform.”
Surprisingly, unlike almost all EDC rivals, Phase Forward already owned a safety application to classify and manage adverse events in clinical trials. But on a technical level, Phase Forward liked Lincoln Technologies’ ability to detect more subtle pharmacovigilance “signals” of drug safety issues amid the noise of thousands of reports. “Signal detection is moving to the forefront of customers’ minds,” says Weiler.
BUYING INTO STANDARDS:
Robert Weiler says customers
are hoping to detect safety
signals earlier, and manage
Weiler says Lincoln Technologies does more than just detect safety signals. “One of the things that attracted us to them is that they do the managing of the signal. How do you manage that signal through to resolution and track it and have the processes around that?”
Indeed, Lincoln functions almost as a safety-oriented contract research organization (CRO) for marquis customers such as GlaxoSmithKline (GSK). Lincoln and GSK won a 2005 Best Practices Award from Bio-IT World for the safety system they built together.
Weiler says the sharp line between the company’s EDC and safety systems will be maintained — the programs will still be sold separately. Lincoln’s tools will be applied to data from third-party data management systems, for example. But for customers desiring end-to-end solutions, Weiler expects Lincoln’s software will be used to view or analyze data from all of Phase Forward’s applications.
“We have an opportunity to take the data from an EDC system, hopefully [Phase Forward’s] InForm, and run signal detection against that data using the same tools the FDA is using against the data,” notes Weiler. “That’s going to be a major differentiator for us in the safety market and the EDC market.”
Weiler says Phase Forward was impressed by Lincoln Technologies’ embrace of CDISC data standards: “We don’t have, I don’t think, the experience or the knowledge of CDISC that we would like to have. It just hasn’t gotten into the fabric here as it has at Lincoln. They’re going to be able to bring that to us and make it part of our fabric.”
Vows Weiler: “That helps us overcome a somewhat real weakness that we have, not a perceived weakness. We are going to be as standards-centric and standards-focused as any company in the industry.”
In some circles, it may take time for Phase Forward to ease doubts that its embrace of standards is in earnest. Elsewhere in the technology industry, dominant companies such as Microsoft, Apple, and Adobe typically prosper with proprietary data formats, then offer cynical support of standards just to twist the standards in their favor. But the hiring of the 30 highly regarded Lincoln Technologies staffers, who include several prominent CDISC volunteers, will likely be perceived as a sincere embrace of standards by Phase Forward.
Weiler remains adamant that this is not just spin. He notes that Phase Forward did participate in many CDISC efforts but vows that future products will more seamlessly incorporate industrywide data formats. “We always had religion,” he says. “We might have been in the back pews. We truly believe we are going to be a leader if not the leader. As a leader, you have to have good products, but you have to be a leader in the standards.”
With the deal, Phase Forward remains one of a handful of companies offering broad, integrated suites of software for clinical trials.