As ClinPage reported recently, Dana-Farber Harvard Cancer Center has been using Phase Forward’s InForm software for clinical trials for a while. But only since the summer of 2006 has the academic medical center embarked on using electronic data capture (EDC) for its largest and most complex trial, a 500-patient study of children with acute lymphoblastic leukemia (ALL).

Among other novelties in the ALL trial, InForm can use the hospital’s patient registration system to populate fields of demographic data needed in the study. That streamlines the work of the clinical research coordinator and reduces the tedium of endlessly re-entering the same information.

What’s more, the academics at Dana-Farber are just as keen as industry to combine EDC and Phase Forward’s drug safety software. The goal: to peer deeply into the oceanic data depths for signals that do not always announce themselves. “Signal detection is a very, very important tool if you’re looking to see how something is playing out in the mass population. We provide those tools,” says Keith O’Leary, senior product marketing manager for InForm at Phase Forward.

O’Leary is in his second year at the company. “It’s been a lot of fun,” he says of the company’s recent growth. “We’re starting to turn a corner.”

Phase Forward’s reporting functionality, he says, was a major reason that Dana-Farber chose InForm. “From an investigator standpoint, they want to get to the data as quickly as possible,” says O’Leary, noting that the business intelligence technology of Cognos is built-in. “We give them the ability to do that in near real time. They have the ability to run ad hoc clinical data reports as well as reports on the operational data. No one else, to my knowledge, is doing this.”

The reports can even tap back into aspects of the trial protocol, O’Leary notes, and be exported into such formats as Excel spreadsheets and Adobe PDFs.

O’Leary says that customers inside and outside academic medical centers are no longer pondering whether EDC is necessary. Nor do they wonder if EDC really works. “The major hurdle no longer is the risk factor,” he says. “The major hurdle is the process change factor.”

Technology purchasers in industry and ivory tower alike, he says, are confronting the same grim reality: “They’ve been feeling the pain of paper and paper-based processes, of poor data cleaning processes. They’re looking for alternatives.” At Dana-Farber and Phase Forward’s other academic customers like Duke, (Mass. General Hospital recently signed on to use InForm for an NIH-sponsored registry), the drive for efficiency is no less intense than in industry.

“They have a lot of pressure to increase the number of studies in their queue while not being able to double or triple their staff,” O’Leary notes. “And they don’t have unlimited funding. That’s where they start to look to technology to be the white knight. We work with these institutions, understanding their budgetary capabilities are a bit different than the major pharma.”

Recently, Phase Forward has supported bi-directional coding of terms within InForm, using the usual medical dictionaries from WHO and MEDRA. “It’s been well accepted,” says O’Leary of the process, which typically mixes manual and automated components. “We’ve given customers the ability to clean the coding data and provide data standardization and consistency.”

With Phase Forward now supporting a web services model, it can publish data to any other application, not just those in the Phase Forward suite. The official name for this feature is an “adaptor,” but the basic idea is simple. “We can publish events coming from InForm, and third party systems can pick up that information,” O’Leary notes. In IT jargon, it’s no longer necessary to use the Phase Forward API.

InForm is obviously not a clinical trial management system (CTMS). But its adaptors and web services allow Phase Forward to support CTMS-like activities, perhaps recognizing that a fourth patient visit should trigger a payment to a clinical site. “We’ve opened up the interoperability of InForm,” says O’Leary. “It’s a programmatic machine-to-machine communication. It becomes an XML to XML communication vs. us having to make certain calls to a database. That whole process was eliminated.”