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eTMF/ISF ensuring inspection readiness


  • 21 CFR Part 11 and Annex 11 Compliant
  • Easy and flexible set up and deployment
  • Intuitive workflow aligned with industry's standards

  • Dashboards providing real time oversight

  • Imbedded training module



 I-Vault is a third generation eTMF/ISF system incorporating:

1) I-Vault (eTMF) is a robust eTMF solution that has been used by large pharma, biotech and medical device companies supporting clinical trials through product submission and approval. I-Vault can either be deployed as a SaaS model, or the technology can be transferred to the client. I-Vault is easily set up utilizing data management staff, incorporating industry standards (TMF Reference Model), or the sponsors/CRO standards (I-Vault is a multi-tenet system enabling multiple views, eliminating the need for organizations to change/modify their labeling schema).

2) eTMF dashboard enables users (based upon security access) to visualize both raw and aggregated data across all trials within the system. I-Vault's eTMF dashboards are easily customized to meet the needs of both the sponsors and the CRO's. System security provides access only to those users identified within the system.

3) I-Vault is integrated with the InSpire EDC system. This enables any and all forms to be produced and imbedded electronically. Edit checks and flow controls can be imbedded into electronic forms significantly enhancing the system, dashboards, workflow and output over traditional eTMF solutions.

4) Imbedded training module enables training materials to be available 24x7 to end users. Electronic test/Quizzes are made available within the system, and automatically scored. If the recipient passes the training test/quiz, an electronic training certificate is populated within the system with email notifications sent to the proper individuals/groups. If the user fails the test/quiz, or does not take the quiz within a set period of time, email notifications are sent to the oversight individuals/groups for follow up. The system manages version control of training materials along with its own dedicated dashboard enabling one user to manage thousands of individuals across all trials with instant data visualization.  

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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