Sharevault Announces ECTD Viewer - Major Advancement Tailored For Biopharma Regulatory Submissions

19 September, 2016

Today, ShareVault is announcing its eCTD Viewer at the 2016 RAPS Regulatory Convergence in San Jose, CA (#2016RAPS, booth 527). ShareVault is the first data room provider to offer integration with an eCTD viewer. The innovative new capability allows for efficient review of biopharma regulatory submissions, such as INDs (Investigational New Drug Applications) and NDAs (New Drug Applications), in the eCTD (electronic Common Technical Document) format. The viewer, developed jointly with DoubleBridge Technologies, Inc., is based on the industry-leading ROSETTA Phoenix™ eCTD Viewer, and is seamlessly integrated within the ShareVault data room.

When biopharma companies share submissions with third parties, the documents typically have to be shared in unprotected format in order to be viewed in an eCTD viewer.  The problem is that then the company has lost control of highly sensitive, confidential information within the submission.  Typically, sensitive information is shared with third parties using one of the leading virtual data room providers, which allows for full control and monitoriing of the disclosed information, including the ability to "remotely shred" disclosed documents, and track user viewing activity down to the page level. The problem is that until now, eCTD submissions shared in a virtual data room do not preserve the structured presentation and inter-document hyperlinks offered by an eCTD viewer, making it much more tedious for third parties to review regulatory submission documents. The new integrated viewer allows for protected sharing of regulatory submissions.

"We are thrilled to be the first data room provider to offer integration with an eCTD Viewer, and we couldn't be happier with how tightly we have been able to integrate with ROSETTA Phoenix, giving our users a simple, efficient and extremely secure solution for sharing regulatory submission documents," said John Badger, ShareVault's co-founder and VP of Marketing and Product.

To sign up for a demo of the new ShareVault eCTD Viewer,  click the button below: 

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