In recent years, the industry has made massive investments in how it gathers data. Electronic data capture (EDC) and patient diaries have pushed growing amounts of data into digital formats.

But what of the other end of the process—where such data emerge for regulatory purposes? To an unfortunate degree, even the best data collection systems can become just another lagoon that must be carefully siphoned into some other system.

Octagon Research has been thinking about the entire life cycle of clinical data and regulatory needs long and hard, helping Wyeth and smaller firms.

FDA Deal

Octagon’s expertise in data standards is sufficiently deep that it recently scored a contract to be one of several firms to help train FDA staff in CDISC.  In addition to a consulting division, the Philadelphia-area company has an EDC solution and a suite of applications under the ViewPoint label that manage regulatory documents such as eCTDs. Just last week, the firm announced StartingPoint, a global authoring system.

Octagon’s vision is broader than most technology firms in the industry. It offers a series of systems to handle clinical data and regulatory forms from start to finish or, more specifically, from the moment of data collection, through cleaning and preparation, and into their proper place in a CDISC-compliant filing. That is not yet a standard view. It is an efficient one, however, with Octagon promising shorter study setup and eCTD preparation timelines.

‘Know The Pain’

Some pharmaceutical companies, of course, expect to preserve antique processes no matter what modern tools are applied. “They buy some technology,” says Dan Crawford, a product strategist at Octagon. “They don’t change their paper process. That’s not going to work. You have to change your process.”

Crawford has been helping tweak Octagon’s acquired EDC solution, and believes it has unique advantages. The system offers PDF-based reports for regulatory or data management purposes on a 24/7 basis, with no fussing required.

So there is no need to call your vendor or CRO to get a report. Says Crawford: “As soon as data is saved, the report is updated. They are able to manage their trial from those reports. They can also export data into Excel.”

Octagon’s revisions to its EDC system after it was purchased, Crawford says, were shaped by the firm’s understanding of the industry’s regulatory needs. Octagon has long made a business out of converting and preparing documents and data for CDISC-compliant regulatory submissions. “We know the pain involved in converting that data to make it submission compliant,” he says. Some EDC solutions, he says, leave that data in a state that is far from ready. “We put a lot of effort into narrowing that gap,” says Crawford. “We had to make sure the output was usable.”

Shadow CRO

In many ways, Octagon’s end-to-end vision for data and systems approximates what contract research organizations have always delivered—except with more emphasis on technology and CDISC data standards to enable large-scale efficiency gains. Crawford says that vision allows Octagon to approach some trials differently than other EDC firms or companies just worrying about regulatory submissions.

Knowing CDISC well, he suggests, helps the company to avoid fairly pointless restructuring and reformatting of the data at various stages. Says Crawford: “We would build your EDC system, collect your data, host it, do the validation and cleaning of the data. You have your submission components and you can put them on a shelf to start your next trial. That’s the benefit of choosing Octagon. We certainly do compete with other CROs in terms of the services we provide. We think of ourselves as a full-solution provider from start to finish.”

75 Nations At Once

Kirk Gallion, Octagon’s president, seconds that notion. He notes the sponsor community is continuing to wrestle with the difficulties of orchestrating simultaneous regulatory submissions around the globe. “Organizations are looking at their clinical programs in terms of how many things can I do in parallel,” Gallion says.

One customer wanted to file in 75 countries at the same time. “It’s a really big challenge, but one that is achievable,” says Gallion. Paper, clearly, presents problems in that situation.

But at the most progressive organizations, Gallion says, Octagon is being asked to help the regulatory process by facilitating the sharing of data from the moment it is created. “People want to work with partners in a more real-time basis,” he says. “I’m talking about more than an eRoom. This has to come together in a way that is really, really simple for a wide variety of people. Just as if the team was sitting down the hall from each other. That’s the expectation. We have a lot of people coming to us saying, ‘How do you make that happen?’ “

Long View

Technology usage is also being driven by tighter budgets, Gallion says. At some small companies, just one or two people maybe doing all the data management and regulatory chores. Technology allows sponsors to be sure that standards and practices adopted for one trial will be reused, leading to less deliberating over the best way to proceed during later projects.

“People are trying to take that long view,” says Gallion. He does concede that some companies still have well-fortified silos and use as much paper as ever. In some cases, he says, sponsors “are still paper centric. They just throw some technology to enable another paper-centric process.”

In such situations, Gallion says, Octagon tries to gently prod the customer toward a future that is faster and easier: “We’re helping people break out of some institutionalized behavior.”