Overview

 I-Vault is PharmaVigilant's electronic Trial Master File (eTMF) system designed to electronically collect, store and manage all documents throughout the life of a trial - allowing sponsors to seamlessly transition their trial master files from paper based platforms to submission ready electronic platforms.

 

Fully Integrated End-to-End Solution for Clinical Development and Submissions

 I-Vault's powerful document management capabilities allow Sponsors to determine which trial documents they wish to collect, and how they would like them organized.  Once determined, I-Vault's robust system of roles and privileges enable the Sponsor to determine which users can view, upload, and/or digitally sign each of those documents.  Documents are scanned in bulk or uploaded into the system, and I-Vault automatically directs them to their appropriate location, eliminating the need to catalog and index these files.   Upon the upload of a document, document dependencies can be configured to require other documents or folders, email notifications can be triggered, and digital signatures and translations added.  Once the files are in the system, users have the ability to create a list or graphical representation of the status of their eTMF, or search for content within a file name or document.  As a result, Sponsors benefit from greater visibility, accuracy and control of the valuable data collected.

 

Features:

 

Batch Scanning

I-Vault will scan barcodes from a batch of documents into one folder. They will then be added to the appropriate file within the folder. The documents will have an established bar code that relates to a corresponding file. An example of how this may be used for a subject's source worksheets containing multiple events.

Document Dependencies

The Sponsor can set the system to require a certain document or folder upon the upload or modified status of another document.

Listing Tool

The Listing Tool is a feature that allows you to filter files by giving the system various search criteria.  The Listing Tool allows you the ability to visualize your search in a pie chart based on the various filters you have selected for your list.

Notifications

Notifications are a feature that will generate an email alert to a user, or list of users, when a predetermined file has been uploaded/scanned into I-Vault.

OCR capability

I-Vault can capture the contents of a scanned document and store it within the system. This allows users to convert their paper documents into searchable PDFs for text search purposes.

Translations

The I-Vault system allows for a translated version of a file to be uploaded.