Media Coverage
CTM Features Added to Phase Forward EDC Tool
Bio-IT World / eCliniqua
May, 2005
Phase Forward has among the broadest offerings in the clinical universe - with one gap. That gap has now been partly filled.
Last week the company announced it will add clinical trial management (CTM) features to its six-year-old electronic data capture (EDC) application, called InForm.
Phase Forward did not develop all of the technology in-house. Cognos will provide some of the power behind the scenes. In a zero-footprint approach, Cognos' XML-based technology will be transparently incorporated into InForm. That will allow users to create dozens of dynamic and fully configurable trial management reports.
Some of the reports are specifically designed to assist monitors with site management, electronic case report form completion, source document verification, and query-cycle times. According to a press release testimonial from Procter & Gamble Pharmaceuticals, it took just hours for that company to use the new system to generate a few reports. It once took days.
Martin Young is Phase Forward's VP for services in North America. He says a broad swath of customers and end-users were consulted about what CTM features should be added. The industry's current challenge, he says, is no longer just getting clinical sites to use EDC. Rather it's helping distant trial monitors to work with sites.
"What we're hearing from the sites is that they have a good grasp on entering the data and query management. The adoption issue is not the issue it was," says Young. "The piece that has been much more difficult has been seeing the benefits from the monitoring and the management."
In some cases, Young says, monitors may hop on airplanes to visit specific sites before a single patient has been recruited. That's a waste of money - and it's not necessarily the monitors' fault. Blame the software, which may not offer much granular visibility into the situation at one particular site. "You should plan visits when it makes sense to visit the sites," says Young.
Phase Forward is not overselling the CTM capabilities that have been added to InForm. "I would not describe this as a [clinical trial management] system (CTMS)," says Young. "All of this data is automatically generated. You get a management system that is data-driven rather than manually entered. This is taking away the issue of getting the data into the CTMS system."
The new CTM functionality cannot create study plans, manage drug supplies or trigger financial payments to clinical sites. Nor can it look for answers across multiple trials. In part, that's because Phase Forward doesn't want to step on the toes of partners like ClinPhone, a specialist in patient randomization. Some big Phase Forward customers have already built in-house systems to manage payments.
The new application appears to have some ability to connect with separate Phase Forward applications and databases; Phase Forward says it will be able to issue generic clinical reports on adverse events but not issue the regulatory reports required under the law.
Young thinks the new features will make InForm more attractive to clinical research organizations (CROs). Some CROs only supply reports on a monthly basis; now the software can supply both standard and ad hoc reports on the fly. Sponsors will be able to see the status of patient recruitment and other metrics - and take action.
Young notes this may generate new dynamics between those who pay the bills for a trial and those who do the work at the site level. "This does give sponsors a more detailed window into what's going on with the study," Young says. "It does give them some interesting opportunities to manage the studies with their CROs. They can actually see for themselves and do ad hoc reporting on what's going on."