eRegulatory

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Veeva SiteVault reduces the complexity of conducting clinical trials by connecting your regulatory operations to improve efficiency and compliance.

Manage regulatory and source documents in a single system that supports 21 CFR Part 11 and HIPAA requirements. With a real-time visibility across trials, SiteVault Enterprise improves operational efficiency, speeds study activation, and enables faster, higher-quality trial execution.

Contact Us

Research Administration

sitevault@augusta.edu

speed

Speed Study Activation

Replace manual processes and design your own workflows to support quality and speed study activation.

Monitor with wireless symbol on it

Enable Remote Monitoring

Provide monitors with secure, direct access to your regulatory and source documents.

visibility

Enhance Visibility and Flexibility

Create your own workflows, reports, and dashboards for greater visibility into start-up timelines and regulatory processes.

SiteVault provides standard document types, document fields, document lifecycles, and other features to help users manage the kinds of documents maintained in an Investigator Site File:

Document Reuse across Studies: SiteVault, can automatically populate and associate documents across various studies. Only current and relevant document versions will be shared so users don’t have to manually maintain which document versions are applicable for which studies.
Study eBinder: The Study eBinder allows users to view all study documents in an easily navigable hierarchy.
Upload Source Documents in Bulk: Save time preparing for monitoring visits by uploading source documents in bulk. Watch Demo

SiteVault also provides a centralized way to manage Individual (Person) Profiles, Organization Profiles, and Investigator Site File documents.

Key features for Principal Investigators:

Electronic Signatures - Simplify approvals and replace printing, faxing, and scanning with fully electronic signature workflows that investigators and staff will love.
Full eRegulatory System - Provide investigators and staff with easy access to study documents through an intuitive electronic regulatory binder that supports compliance with 21 CFR Part 11 and HIPAA requirements.

Document Retention Period - Study documents can be stored for 25 years following the date of study creation.
Standard and Configurable Workflows - Save time and centralize tasks with built-in workflows for eSignatures and certified copies. Design your own workflows to support quality and speed study activation.

Key features for Remote Monitors:

Remote Monitoring - Provide monitors with secure, direct access to review regulatory and source documents to assist monitors with source data review (SDR) and source data verification (SDV).
Version Compare - View changes between two versions of a document with version comparison tools. Changes are highlighted eliminating the need for a line-by-line comparison.