The world of FDA submissions is about to change. As the FDA announced last fall, several 1999 guidances were withdrawn.

And as of January 2008, electronically submitted new drug applications will have to be submitted using the electronic common technical document (eCTD) format. “Since that news came out, we’ve experienced a windfall of requests for proposal help and software help,” says Jim Reilly, a consultant with implementation services at Octagon Research.

Octagon now has a headcount of more than 200. A third of those folks do nothing but prepare submissions. They are probably more efficient than the typical company in the industry, just by virtue of handling 25-30 submissions at one time.

Part of the reason they can do that is that the company has an enterprise-level software package called ViewPoint.

Octagon specializes in helping second and third-tier companies to manage regulatory issues fluidly and easily, without vast permanent staffing in regulatory affairs. The company’s platform, Reilly says, “allows for the work to be provided to the right people at the right time for the right task.”

Before Octagon developed real applications for managing regulatory documents, it did what many companies do—worked within the existing directory and folder structures of a network or desktop computer. This can work. It can also turn into a nightmare. “It’s risky,” says Reilly. “You can have people moving folders, deleting folders.” If someone wants to revert to an older version of a document, it can be hard to recover.

In the early days, he notes, the company got unfinished submission data sets from customers. “In large part, most of them were raw and unformatted,” Reilly says.

The company makes tools to create, manage and view documents for regulatory purposes. The idea is that anything in the process is an “object”—a document, a process, a role can all be represented in the system.

So ViewPoint is both a project and a document management system. In addition to the paperwork, Octagon’s software offers a way to handle issues and road blocks that arise, as they always do.

Does someone at the FDA have a question about page 432-AA-97c? Is a new version of a form needed? Did Steve stall everything by going on vacation and forgetting to read something? Is everything there? Does something need to be recalculated?

The usual real-world obstacles and reversals with the eCTD are so common in every filing that the software and work flows need to accommodate them, Reilly observes.

Once the system knows about the issues, reports on them can be run. As the bumps and changes in route are studied, the system can provide opportunities for efficiencies. Real management, in other words. Not just muddling through. “We are making submission management a science,” says Reilly. “There is no tool that does that now. When we plan for a new submission, we can put together a pretty accurate plan. Before, it was a shot in the dark.”

As Octagon’s ViewPoint product has evolved, it can handle just about any input, including images, SAS files, Microsoft Word documents, XML and even video.

If you don’t want the repository that comes with the system, you can point the Octagon software toward your Documentum system, and it will take matters from there, preserving the user privileges and rules that have been encoded there. “It’s never going to step outside the bounds of Documentum,” says Reilly. “It is going to respect the rules and permissions.”

At last December’s public hearing on the eCTD, Reilly reports, some attendees believed that the FDA may have been floating a trial balloon. (We wrote another story about that meeting, also referencing Octagon.) The audience basically asked the agency, “Hey, are you serious about that withdrawl?”

As Reilly notes, “it was asked more than once, as if [the FDA] were kidding.” He assured ClinPage the FDA is not joking and is not just testing the waters: “The FDA is clearly moving to electronic. We’re trying to get our clients ready.”

Which doesn’t mean an electronic submission is obligatory. The French, for example, still require paper. It’s still possible to use paper in the U.S. No need for complete panic, okay? But the clock is ticking. Hybrid submissions, combining paper and electronic formats, are transitioning into the realm of historical artifacts.

As Reilly related, Octagon was founded in 1999. He was employee number 25. Its role was to manage the clinical trial data after the conclusion of a trial. As the industry has evolved, and the Clinical Data Interchange Standards Consortium has grown up with the company, Octagon has more than a cursory interest in data standards.

Standards are in the company’s interest, simply because it interacts with so many sponsors and regulatory agencies. It has employees active in CDISC and helps to train companies in clinical data standards. “We are the de facto provider of CDISC training worldwide,” says Reilly. “If you’re getting training on the study data tabulation model (SDTM), we’re doing it.”

The company is also providing services, converting older datasets into SDTM. The FDA has begun signaling to the industry that the CDISC standard will become the standard for clinical data, just as eCTD is the norm for documentation. “People are taking that less lightly,” Reilly says of the SDTM, taking note of FDA statements on the issue. “It was the same language they were using with eCTD.”

In many cases, Reilly points out, smaller sponsors do not and should not have personnel in-house who are as well versed in SDTM or eCTD as he and his organization. They know the stuff cold so you don’t have to.

The way forward? Reilly says that increasingly, the industry will be considering a fully electronic life cycle for regulatory documentation.

At the moment, to take a biological analogy, the documentation move back and forth between paper and electronic realms as needed, the way that a frog may live on land and water at various times during its life. In the future, Reilly thinks, it will become increasingly impractical for that to be the case in the industry. “Everything we start to analyze needs to be in electronic format for a host of common sense reasons,” he says.

Reilly says the process of sponsors wanting to make the process completely electronic is not something that will happen over night. “The adoption is slow,” he says. “But the FDA is pursuing it—the idea of electronic only. It’s really gathering steam from last year.”

There are a few myths that can be dispelled about the eCTD: “There is a misconception that you have to use the FDA viewer tool,” says Reilly. “It’s not the case.”

In View Point’s eCTD solution, eCTD Complete, you can easily preview the entire document prior to sending it to a regulatory agency. The software automatically checks the organization of the eCTD, making sure the application number and the “leaf” structure are in the right places.

The life cycle of the submissions can be accurately tracked. There are also built in ways to check a document without doing a full-blown verification. Reilly is especially keen to demo the search functionality, which (as we saw in a demo) is blazingly fast. You can even search a leaf that has been replaced.

In general, Reilly says, View Point offers immediate visibility into the status of the regulatory submission: “What is going on with this document at this very moment? It’s a visibility tool.”