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
Speed Study Activation
Replace manual processes and design your own workflows to support quality and speed
Enable Remote Monitoring
Provide monitors with secure, direct access to your regulatory and source documents.
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
- 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
- Upload Source Documents in Bulk: Save time preparing for monitoring visits by uploading source documents in bulk.
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.
- Unlimited Document Retention Period - Preserve your regulatory documents for as long as you use Veeva SiteVault.
- 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.
Access and Training Information
Access and Training Information for AU's Regulatory Users, Study Staff, Budgets/Financial
and Auditor/Inspector Roles
Access and Training Information for Monitors, Sponsors and CRO's
Getting Started for CRA's and Monitors
Remote Monitoring for Sponsors and CRO's
Watch this short video to learn how VEEVA helps clinical research sites and institutions focus less on technology,
and more on research.