PharmaVigilant Releases I-Vault (eTMF), Version 2.7

New State-of-Art Features, System Optimizations, and Performance Enhancements to ensure Inspection Readiness

WESTBOROUGH, Mass.--(BUSINESS WIRE)--PharmaVigilant, an e-clinical provider, is pleased to announce the release of I-Vault 2.7, the most robust eTMF system in the industry. I-Vault 2.7 has been expanded to include the new I-Batch uploader, imbedded Redactor tool and the Report Generator. I-Batch enables high volumes of documents and images to be uploaded into the correct location with a click of a button. The Redactor tool ensures privacy while maintaining an audit trail, and the Report Generator enables the sponsors to export their customized data automatically with a corresponding indexed table of contents in PDF format. I-Vault has been scaled to 25 Terabytes to ensure that it can handle the largest programs and or systems

“I-Vault 2.7 proves that PharmaVigilant is continuously broadening and enhancing our products to support our clients and enable sites to overcome key research challenges.”

I-Vault 2.7’s new feature, I-Batch, allows users to select a collection of unorganized trial documents to upload, and each file will be automatically inserted into its correct electronic location, regardless of file type. This functionality has been successfully validated on zip folders containing up to 168mb of files, inclusive of image files. As a result, I-Batch bypasses the manual filing process and improves the accuracy of file uploads, saving a significant amount of time and cost.

The Redaction Tool within I-Vault is scaled for large document processing. The redactor feature can remove patient names and other sensitive or confidential information from electronic files, regardless of the number of pages or megabytes. Providing control over patient privacy is critical to all successful implementations.

The Report Generator enables users to integrate data from multiple systems into one indexed, downloadable PDF report. The Report Generator delivers this information in the quickest, safest, and most streamlined way - encrypting the PDF report into a zip file to strengthen the security around the patient’s data.

I-Vault 2.7’s listing tool, allows you to filter files by giving the system various search criteria, has also been upgraded to a faster speed for reporting and graphing. The listing tool is a key feature used to analyze the status of trial documents, and estimate trial master file completeness. The user can now filter and report on millions of distinct document detail combinations, and generate graphical representations of listed information in seconds, so the system can be ready for inspection in a shorter period of time, with a significant reduction in sponsor effort.

PharmaVigilant has optimized the search feature in I-Vault 2.7, resulting in significantly quicker search response times. This upgrade allows users to quickly search and isolate specific trial documents in their eTMF to increase search flexibility and efficiency. Search speeds are critical issues as they impact a system's usability and total cost of ownership, so the fact that I-Vault 2.7 can now display the stored documents at faster rate is a crucial scalability upgrade.

“I-Vault 2.7 puts us years ahead of the competition technically in scale and scope. We are moving more data, faster, accurately, and at a significantly lower cost per document than anyone else in the industry. We have incorporated configuration tools and workflow enhancements that enable the product to be Sponsor process agnostic,” said James DeSanti, President and CEO, PharmaVigilant. “I-Vault 2.7 proves that PharmaVigilant is continuously broadening and enhancing our products to support our clients and enable sites to overcome key research challenges.”

About PharmaVigilant:

Based in Westborough, Mass., PharmaVigilant is a SaaS company providing industry leading technologies to streamline the clinical trial process for biopharmaceutical companies. Its full suite of patient-based technology automates the collection, management and analysis of clinical trial data and most importantly puts that data in the sponsors’ hands when and how they want it. Sponsors rely on PharmaVigilant to ease the regulatory and FDA submission and approval process. For more information, visit www.pharmavigilant.com.