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After Further REVIEW at the FDA

Clinical Trials & Research
Winner: FDA nominated by GlobalSubmit
Project: Common Table of Contents

July 29, 2010 | The U.S. Food and Drug Administration (FDA) doesn’t often bask in the spotlight of positive press, which must make the 2010 Best Practices Award in Clinical Trials particularly gratifying. This award recognizes a key innovation that is helping to spur the adoption of the electronic common technical document (eCTD), which Bio-IT World reviewed in depth last year (see “Learning to Embrace the eCTD,” Bio•IT World, May 2009).

A major reason for the steady increase in eCTD adoption over the past couple of years, particularly among the larger pharma companies, is the successful implementation at FDA of GlobalSubmit’s REVIEW software. However, that relationship did not come about by accident. “We talk with the FDA weekly,” says Jason Rock, chief technology officer at GlobalSubmit. “We work with them hand in hand on how to make the system more reviewer friendly.”

FDA had initially tried to build its own software, but “it didn’t work out too well,” says Rock. “Reviewers were rejecting it, [saying] eCTD would never work.” When FDA put out an RFP (request for proposals) in 2006, Rock’s Philadelphia-based company consisted of just two employees. “Our competitors were looking to sell to pharma, so we said, ‘let’s court the FDA and figure out their needs.’ If we could get the FDA to buy, the industry would follow.” As there were no rules preventing Rock from requesting meetings with FDA, he did just that, learning what features the agency was looking for.

In January 2008, FDA officially adopted the eCTD as the preferred format for electronic submissions. Adoption has grown from 1,000 eCTD submissions annually to 40,000 eCTD submissions per year. “If you do electronic filings, you have to use the eCTD,” says Rock, noting that FDA has received more than ten times the number of eCTDs than the rest of the world. “Every single eCTD—over 130,000—has gone through GlobalSubmit’s software,” he says proudly. “Every time a reviewer looks to review a submission, they open our software. Then they get to work.”

GlobalSubmit’s software does not create the actual eCTD, but does the review and validation. The REVIEW software allows reviewers to examine eCTD submissions for technical accuracy and assess regulatory activity. Unlike the old systems, which could take up to half an hour to open, REVIEW opens a large submission in a matter of seconds. It is currently the only eCTD review software used at the FDA. FDA is also using GlobalSubmit’s VALIDATE software. Before this tool was implemented, submissions would often have missing or duplicated information, and key documents could be impossible to find.

Increase Adoption

While FDA’s intent is to increase the adoption of the eCTD, Rock is fairly blunt in his assessment of FDA’s efforts in that regard. “FDA, quite honestly, doesn’t do as much as they should to increase adoption,” he says. Yes, they present at DIA meetings, publish notices, and so on, but “they don’t have anyone going out there to work with small companies. They don’t have a PR firm.”

While the use of the eCTD by major pharma firms is fairly mainstream, many smaller companies are hesitant, seemingly content to file INDs using paper. “The small guys are comfortable with paper,” says Rock. The perception is that there are no real cost savings, and that FDA won’t review the submissions any faster. Moreover, there are risks and costs associated with switching over, including new software licenses. Paper INDs can be printed and managed in a few Word documents.

That isn’t hurting GlobalSubmit, however, which now has some 20 employees and is in discussions with Canada and Japan for additional licenses. Rock still aims to expand his primary customer base, the drug companies; 70% of the top 20 drug firms are clients. But with FDA continuing to encourage companies to switch to eCTD, Rock says his company will soon be releasing new publishing software to create the eCTD submissions in XML.

This article also appeared in the July-August 2010 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.

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