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eSubmissions software aids companies without IT, regulatory resources.

By Ann Neuer

Feb. 1, 2008 | Many large pharmaceutical companies were sitting pretty on the January 1, 2008, deadline for required use of the electronic common technical document (eCTD) for electronic submissions to FDA. But the rest of the market is in a very different place, says Lisa Meyer, director of marketing for Image Solutions Inc. (ISI), a provider of electronic submissions software and services.

“Big pharma has been looking at the eCTD as a strategic trigger to examine how they conduct business and how they need to re-design processes to comply with changing regulatory requirements. Smaller players don’t have the IT or regulatory resources to go through the process internally so they are turning to outsourcing,” Meyer explains. Even bigger companies are opting to outsource rather than risk a “Refuse to File” decision.

“Customers, whether big or small, want choices,” Meyers says, and to meet that demand, ISI offers a range of software solutions that enable in-house operations coupled with outsourced services. As needs change, customers can modify their packages, add to them incrementally, or outsource the entire process.

ISI has processed more than 600 eCTDs and holds a 40 percent eCTD market share among the top 50 pharmaceutical companies with its eCTDXPress product. To handle the anticipated growth in outsource volume, ISI has opened operations in Tianjin, China, to handle back office functions such as the processing of case report forms (CRFs).

According to Meyer, ISI is finding that a few emerging companies have never heard of the eCTD. Others may have heard of it, but a focus group held this summer revealed that many are convinced that FDA will not enforce the eCTD standard.

Meyer says, “The reality is that eCTD is here. The challenge for ISI is to bring the right expertise to the table for the companies that don’t know what questions to ask or understand how implementation of eCTD will impact their business processes.”


This article appeared in Bio-IT World Magazine and eCliniqua eNewsletter. 
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