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SiteVault eISF

An electronic investigator site file simplifies management of regulatory documents, enabling compliance and efficient monitoring for clinical trial sites.

Solution by Veeva Systems
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Overview

The SiteVault eISF platform eliminates the need for paper binders, offering clinical trial sites a compliant and organized electronic system for managing investigator site files. It reduces administrative workload, helping research teams concentrate on essential tasks.

This system ensures consistent record-keeping and provides study teams and monitors self-serve access to essential information. Compliance with global industry standards, such as ICH-GCP, is supported, applicable to all studies.

Key Features

  • Electronic Regulatory and Patient Binder: Effortlessly maintain and access regulatory and source documents electronically, aligning with industry regulations.
  • Remote Monitoring: Facilitates secure access for monitors to review documents, supporting source data review and verification.
  • eSignatures: Expedite signature processes by enabling electronic signing of documents from any location.
  • Digital Delegation: Automatically populates delegation logs, enhancing visibility into staff qualifications and assignments while maintaining compliance.
  • Central Documents: Store and update essential documents, such as licenses and certifications, across studies in a unified location.
  • Seamless Sponsor Collaboration: Exchange documents with sponsors and CROs efficiently through Veeva Clinical applications.
  • Reports and Dashboards: Access real-time study visibility through customizable reports to manage workloads and monitor progress.
  • Workflows: Manage document-related tasks with streamlined workflows for approvals and signatures.
  • eConsent: Enhance patient experience and site efficiency, optionally available for expanded use.
  • Enterprise Options: Upgrade for features like Single Sign-on, API support, and dedicated customer support.

Testimonials from users highlight the platform's impact on reducing monitoring visit times and easing regulatory document management. The system supports robust information security practices and allows significant data retention capabilities, accommodating diverse user and study needs.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Clinical & TrialsQuality & Compliance
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Tag(s)
Quality & Compliance Management