ShareVault and ECTD Inter-Document Linking

31 July, 2012

One of the more interesting things we’ve encountered with our biotech clients is the hyperlinking of documents associated with regulatory filings such as an IND (Investigational New Drug) or an NDA (New Drug Application). These submissions can be done using the paper-based CTD (Common Technical Document) format or completed via electronic filing using the eCTD format – an elaborate structure allowing internal hyperlinks between documents.

eCTD Structure

Because of the very confidential nature of eCTD document sets, they are often uploaded to ShareVault for two secure external processes – 1) communicating with outside regulatory advisors in preparation for a regulatory filing, or 2) the sharing of previous filings with prospective partners, investors, potential acquirers, or other third parties. 

In response to the rising need within our client base, we’ve built in a feature set that enables these processes. The first step was to pre-create CTD and eCTD modules and folder hierarchy within ShareVault. If you’re familiar with CTD and eCTD, you know that they are multiple levels deep and in the case of eCTD, more than 250 folders. Having this structure already in place when a biotech starts the regulatory preparation process saves them the cumbersome effort of having to manually create it when they move to a cloud-based repository.

The second area we addressed ties back to hyperlinking documents. When eCTD documents are prepared within an eCTD publishing tool, they may refer to other documents in the set using hyperlinks. Since these documents are stored in separate folders, the links between them have a relationship that allows them to be moved without breaking. Unfortunately, these relationships do not persist when uploaded to typical cloud-based document repositories as they can’t preserve the hyperlinks. At ShareVault, we know how important this is, and after extensive development, we’re pleased to be able to offer full eCTD Inter-Document linking capability to our biotech clients.

The third significant requirement that ShareVault has addressed is size. By the time a drug reaches Phase 3 in the clinical trials process, an NDA document set will have grown quite large in both document size and quantity. In some cases, the documents may be thousands of pages in length and, as in the case of one ShareVault customer, can reach more than 80 GB in total volume. Other cloud-based repositories struggle to handle viewing of documents more than a few hundred pages in length. With ShareVault, that’s not a problem.