We’re wearing our flame-retardant pants today, just in case anyone sends an email our way.

Wayne, Pennsylvania’s Octagon Research recently purchased Ninaza, a financially troubled electronic data capture (EDC) company in California. Ninaza had specialized in registries and post-approval trials. It’s an interesting acquisition for Octagon, with potentially far-reaching ramifications for clinical data management in the pharmaceutical industry.

Octagon, for those not familiar with the firm, has 100 customers and specializes in the management of regulatory data and documents. It has standalone software and a consulting practice to help customers manage submissions and other filings, whether on paper or electronically.

Octagon’s entire vision of the life cycle of clinical data is broader and more comprehensive than most. It will not work for every sponsor. But Octagon’s view could herald an era in which data might not back up and get stuck like water in old pipes.

Seeing It Fresh

“We are looking at the entire clinical research and development problem as a process problem,” says Jim Walker, Octagon’s chairman and CEO. “We are not trying to be functionally isolated in our offering. The current outsourcing model is antiquated and needs to be reviewed. The true efficiencies are over the entire enterprise solution.”

As such, Octagon is embracing a more holistic, monolithic technology landscape in which one system collects, cleans and ultimately disgorges clinical data.

He recognizes the message will be hard for some to accept, simply because of all the work that has gone into implementing EDC. “People have to sit back and challenge their traditional thinking,” says Walker. “We don’t seem to be making headway with our time lines or from a cost perspective. We need to think about this differently.”

Issues With EDC

Walker doesn’t have a problem with EDC per se. He just acquired the means to provide it, obviously. But he doesn’t think EDC has relieved any of the intense cost and time pressures afflicting clinical development in the industry. Says Walker: “EDC is definitely getting more traction. But that alone is not going to solve the problem. People are paying a lot of money for the technology. The dollars would be better spent focusing on the process problems.”

Walker says that data standards, especially those from CDISC, will allow a more seamless, less serpentine path for data from the clinical site, through data management and analysis, and on to regulatory agencies.

He is perfectly diplomatic, completely civil. But Walker thinks EDC is a problem wrapped up inside a solution. The solution is to get clinical data into a system. Done. But the problem is that, as Octagon itself has discovered, data from some EDC systems is not always suitable for regulatory needs.

Mopping Up

Octagon can and does welcome such cleanup projects, Walker says. But as an efficiency-oriented individual, it seems to offend him that his firm needs to spend any time attending to the not-so-little messes created by other technology outfits. “We’ve had to rework the output of how the case report forms (CRFs) are formatted,” Walker notes.

We realize those may be fightin’ words to some in the industry, and hasten to add that sponsors, not EDC suppliers, design the CRFs. Issues with EDC cannot be blamed solely on those supplying the technology. We asked Octagon for some clarification on how EDC may be used and implemented in ways that create downstream problems for regulatory professionals. ClinPage welcomes from readers on this question.

Submission Remediation

Walker outlined a few issues with EDC from his firm’s perspective, noting that “some problems include Acrobat PDF form fields and controls remaining active instead of static; and non-compliant font embedding, bookmark structures, and audit trails. We have also encountered multiple PDF files per patient that need to be concatenated to one PDF. In addition, we have even had to have screen shots printed and then scanned to get a complete case book. We have found variable names in the EDC database that need to be remapped to e-submission-compliant variable names for the submission data sets; multiple adverse event data sets that need to be combined into one data set; and variable names [that] do not match the annotated.” That’s quite a list, isn’t it?

Walker, for his part, says it’s surprising that the overall cost of clinical data management has not dropped. “The major problem is the cost goes up, even with all this marvelous techonlogy,” he says.

Process, process, process

“In our opinion, EDC alone doesn’t bring the improvement folks are looking for from a cost perspective or a timeline perspective,” Walker says. He adds the following about the EDC community: “They are optimizing their piece of the process at the expense of the entire process. A lot of their work needs to be reworked in the downstream process. We can say that because we do a lot of it.”

Selected customers, Walker reports, have asked Octagon for EDC. “They understand our vision of getting rid of the waste and the rework,” he says. “Our EDC purchase was to fill a technology hole. We tried a lot of other EDC solutions.”

Regulatory + EDC System

Ninaza as a business was a well-regarded company, but it had been limping for some time. We’d been trying to talk to the company for six months without any success. The critical question now is whether Octagon can do more with the Ninaza software than Ninaza itself could. Only time will provide that answer.

Walker reports the Ninaza technology was closely scrutinized by Octagon’s IT wizards as part of the customary due diligence process. Says Walker of Ninaza’s EDC tool: “It has even greater potential when combined with our current platform,” his ViewPoint suite.

Octagon is at the forefront of helping customers prepare electronic common technical documents (eCTDs). Walker says that world and the CDISC realm are going in the same direction. “CDISC and eCTD are big initiatives. We look at those converging. A lot of people look at them as separate.”

All too often, Walker says, the irony of EDC is that it’s not always generating data suitable for electronic submissions. People in one part of a company will triumphantly finish their labors and loft their data into the expectant laps of regulatory professionals. Walker picks up the story: “And regulatory says, ‘this is good, but I am going to need to rework this to get it into the standard I need to for electronic submissions.’ ”

Size Doesn’t Matter

So the Ninaza EDC and the Octagon regulatory applications work are integrated now. They will be seamlessly combined into one application at some unspecified date in the future.

Walker can offer no generalizations about which types of companies appreciate the Octagon thinking: “We’ve had top 10 customers get it. We have small shops, medium shops, get it.  It’s not about the technology, but who’s attuned to the cross functional process and the standards that are out there driving this.”

One final note: Octagon says it has retained a few key Ninaza employees to help with the transition. But in the past few weeks, Ninaza founder Hugh Levaux has joined Medidata Solutions. His title: VP of product strategy. That appointment leads us to speculate that other EDC companies may be considering an expansion of their downstream functionality and the addition of the ability to generate truly submission-ready data.