Veeva Vault Safety
Veeva Vault Safety is the only modern application for the collection, management, and real-time oversight of adverse events.
Outsourcing with legacy systems behind corporate firewalls has left organizations with insufficient visibility, fragmented data, and ineffective access to safety information.
With the ability to manage adverse event information and documentation in a single system, Vault Safety enables sponsors to make faster, more informed decisions and improve compliance throughout the product lifecycle.
- Improve oversight to reduce risk: Real-time reports and dashboards and seamless collaboration with partners provides the necessary visibility for risk mitigation and compliance.
- Streamline case management: Gain efficiencies with a modern safety application built for today’s regulations and best practices.
- Stay current: Access new capabilities and the latest regulatory requirements with easy and automatic upgrades.
- Unified: A single cloud platform for safety, clinical, regulatory, and quality eliminates silos and drives end-to-end safety processes.
CASE PROCESSINGStreamline adverse event management with role-based assignment and routing of cases for follow-up and medical review, and intelligent duplicate detection and follow-up.
SINGLE SOURCE OF TRUTHImprove collaboration, safety information and document quality. Sponsors and CROs leverage the same files across Vault Quality, Vault Clinical, Vault RIM, and Vault MedComms to author, review, and approve safety information and documentation.
BUILT ON MODERN INDUSTRY STANDARDSBased on the latest International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E2B R2/R3, E2C R2, E2F) and International Organization for Standardization for the Identification of Medicinal Products (ISO IDMP) standards to align with GxP practices globally.
DICTIONARY SUPPORTSupports the industry-standard World Health Organization Drug Dictionary (WHODrug C3), the Medical Dictionary for Regulatory Activities (MedDRA), and the Unified Code for Units of Measure (UCUM).
HEALTH AUTHORITY REPORTING AND SUBMISSIONSProvides full electronic submission of Individual Case Safety Reports (ICSR) and periodic reports throughout the entire product lifecycle.