Octagon Research has announced its ability to interoperate with an electronic FDA system managing regulatory filings.

Octagon has fulfilled the technical requirements to send electronic submissions to the FDA’s Electronic Submission Gateway (ESG) in a production environment. The ESG registration process requires transmission of compliant test data. Preparations and testing include acquisition of a digital certificate, submission of a letter of non-repudiation and confirmation of system requirements.

Nancy Smerkanich, Octagon’s vice president of regulatory affairs, said the development was a milestone: “This efficient method of transmission allows us to provide extended value to our service clients. By sending outsourced submissions through the gateway, we are shaving time from the submission development process that was previously wasted on traditional mail methods.”

Guidance, Gone

ClinPage caught up with Smerkanich not long ago. She was walked us through what the FDA did and did not do last fall. As some readers know, the FDA withdrew previous guidance on electronic submissions to focus its resources. As of January 2008 FDA will shut down several other submission types and require sponsors to rely on the electronic common technical document (eCTD) format for those electing to submit electronically. Paper remains an option; the use of an electronic submission is not being mandated at this time.

Smerkanich, as it turns out, testified at an FDA hearing on the subject last year. She’s got a few decades of experience in the industry and previously worked as a consultant, and at Merck. “They’re really designating the eCTD as the format moving forward,” she says of the agency. “That’s important. That’s their way of saying, ‘We’re getting rid of paper next.’” No more will hybrid paper-electronic applications or an e-NDA be a legitimate format for submissions.

Biggest Shift Since ‘99?

“Some people misinterpret the withdrawal of the guidance that they should go back to paper,” says Smerkanich. “That isn’t what the agency is saying. People should be looking at the future of electronic regulatory submissions and the eCTD.”

How significant is the FDA policy shift? “It is as significant as the 1999 guidance that allowed companies to file the review and the archive copy electronically,” she says. “They’ve been talking about this for quite some time. It’s not a surprise to those of us who have been watching.”

So with perhaps a year to go, Smerkanich says, it’s time to get started. “Companies need to prepare. It’s not something you turn a switch on and do overnight. There are number of process changes that need to be made.”

Slow Shift

At the FDA hearing, she reports, she was informally speaking for the concerns of small and mid-sized sponsors wrestling with a migration to the eCTD. Smerkanich says that there are savings to be had. The catch? One option is outsourcing the creation, tracking and management of the regulatory documents. Another is to provide adequate internal resources for developing the same capabilities in house.

Octagon surveyed customers about their usage of the eCTD. Smerkanich says the company received comments both supportive and hesitant about the eCTD. For some respondents, moving toward the eCTD is just a reflection of the largely electronic environment in which all clinical data are collected and managed. “We collect the data electronically in a database, we process the documents electronically,” she notes. “Why not submit them electronically? It’s the next logical step. It’s high time we leverage the tools that are around us.”

Training Helps

Some of those tools include Octagon’s ViewPoint, an eCTD viewer and regulatory document management system, as well as a lighter application (eCTD Complete).

She’s quick to add, however, that understanding the structure and purpose of the eCTD will require more than just going out to buy any bit of technology. Says Smerkanich: “eCTD is not just about the tool. It’s about the training and the process. Don’t let your eCTD solution be solely an IT decision. It has far reaching consequences for all of the people who touch a submission. Companies that have gone down that route have been burned. They’ve paid a price.”

And considering the entire life cycle of the regulatory process may be prudent, she suggests. “We really are looking at the format of electronic submissions throughout the process, not just at the end. If you wait and try to do all this at the end, it is both time-consuming and expensive. It’s like never getting your oil changed and waiting until your transmission blows out on you.”