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eTMF/ISF ensuring inspection readiness


  • Electronically collect, store and manage your entire eTMF/ISF
  • Maintain an accurate record throughout the documentation management process
  • Receive maximum  visibility, accuracy and control of your data

  • Enables both sponsor and sites to be Inspection Ready



 I-Vault is PharmaVigilant's eTMF/ISF system is a multi-tenet solution that enables users to maintain multiple naming conventions. Both sponsors and service providers can maintain their own current naming converntions (standards), eliminating the need to modify their internal systems, SOP's, and internal/external training. I-Vault's state-of-the-art Data Cube technology; a powerful, multidimensional solution that allows every document, image, and video from your clinical organization to be digitally stored and accessed in I-Vault  with the highest security and control in the industry. Sponsors can seamlessly transition their pre-clinical, clinical, regulatory, data management, and R&D contents from the high-tech Data Cubes directly into their eTMF structure to generate a submission ready electronic platform.


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 can be mass imported into I-Vault  Data Cubes and dragged into their appropriate locations in the system, or can be scanned or uploaded in bulk and automatically placed in their appropriate location.


Upon the insertion of a document, dependencies can be configured to require other documents or folders, email notifications can be triggered, and digital signatures and translations added. I-Vault can also store and stream videos with its embedded video and Dicom viewers. Once the files and videos are in the system, users have the ability to create and export reports on the status of their eTMF. As a result, Sponsors benefit from greater visibility, accuracy and control of the valuable data collected while meeting regulatory requirements. 




I-Vault multi-tenet system enables organizations to Bring their own standards (BYOS). The system allows diverse naming conventions to be used,  all rolling up to the master standard. Sponsors and or CRO's can work with a diverse group of vendors/partners and never have to change their standards or pay to have them converted at a later date. This also eliminates significant time and expense related to design, mitigation, and least of all training.  


Data Cube Technology

I-Vault  Data Cubes are integrated into the I-Vault  system and act as repositories that allow for the efficient collection and dissemination of your important disparate documents. Dragging documents from a Data Cube into an I-Vault  placeholder creates both an audit trail and an automatic backup, while maintaining the highest levels of security.


Enhanced Flexibility

The drag and drop capability allows any document or folder to be dragged into another location within I-Vault  in seconds, with a full audit trail detailing the movement.

Video Viewers

Embedded video players and Dicom viewers can store and stream videos, audio and images in 46 different formats.

Batch Scanning

PharmaVigilant's I-Batch scans large volumes of documents with minimum human intervention.  I-Batch enables sites/Sponsors to scan documents into the system in bulk, getting the right document to the right folder, everytime.

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 robust feature that allows you to filter files by giving the system various search criteria.  The Listing Tool enables the user to drill down to the document level with one click.


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-Vault3.


Regulatory documents can have expirations added to any document to alert both the Sponsor and the site that files need to be updated.

Audit Trail

I-Vault  has the industry's most robust/detailed audit trail.  This provides transparency into the document life-cycle, critical for inspection-readiness and remote inspections.


The track function can be added to any document.  This enables the user to be electronically notified any time a document has a change made to it by another user. This function is used extensively in site initiation packets and contracts.


An approval workflow is incorporated into the system, enabling an electronic review/approval process by the TMF specialist and for data management remotely.


The flag function alerts other users that an action defined by the Sponsor needs attention.



I-Vault  allows for the redaction of files that have been uploaded into the system. This allows for enhanced patient security by ensuring that all files that need to be redacted can be redacted quickly and easily.



Electronic signatures can be added to any form, eliminating scanners and wet signatures.

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.


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


Investigator Site Files (ISF)

Electronic Investigator Site Files (eISF) are easily designed at the beginning of the clinical trial, in parallel with the electronic trial master files. As both are required to be reviewed prior to final trial close out, the design, interaction, and final export and archiving plan should be completed prior to the trial going live.

The eISF design is 17 distinct categories with 75 sub folders ensuring a comprehensive eISF solution for all of your sites. The eISF is easily configured to meet specific site demands regarding addition/deletion of categories and folders if so desired.

eISF are more accurate and of higher quality than paper systems, due to their transparency, use of digital oversight and ease of review. eISF are cloud based, so that they are accessible from anywhere globally, providing file access to the proper individuals (based on rights and roles) within seconds. eISF provides a comprehensive audit trail, corresponding document metadata, and an excellent foundation for inspection readiness in an efficient, cost effective environment.

Sponsors providing eISF for their KOL's and sites increase their site equity by supplying this cost effective, value added service.


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