CLIENT CASE STUDIES

Midsize Pharma Manufacturer, Veeva Vault Implementation

A Midsized Pharma company focused on clinical trials faced challenges in managing their Safety database and processing cases. As a solution, the Company implemented Veeva Vault to manage the safety database. The project adhered to strict GxP and CSV regulations.​

CHALLENGES

  • Multiple major GxP audit findings over prior 3 years, triggering CAPAs​
  • High risk of regulatory non-compliance: ineffective audit trail, missing critical features, manual processes prone to error, functional limitations​
  • Insufficient workflow automation and system reliability concerns​
  • Issues with MedDRA updates and SMQ processing​
  • Insufficient vendor support for evolving safety team needs​
  • Inability to scale with complex clinical studies​
  • Risk to patient safety and study integrity:​
    • Significant threat to clinical trial integrity​
    • Patient safety at risk due to unreliable safety data​

SOLUTION

Strategic Vendor Selection:​
  • The company selected a new Safety Database vendor for clinical trial needs​
  • Veeva chosen as the preferred solution – implementation of Best Practice Vault Safety​
  • The company leveraged pre-built workflows and native capabilities to minimize customization​
  • Focused on scalable, compliant architecture for long-term use​
  • Migrated legacy case data, transmissions, attachments​
  • Data migration performed by third party – standardized medical coding and submissions​
  • Enabled integration of WHO Drug Dictionary and MedDRA​​​

RESULTS

Seamless Go-Live & Operations:​
  • Case processing initiated with no obstacles or blockers​
  • System stability ensured continuous operations and user adoption​
  • Migrated ~1,700 legacy cases and 16,500 attachments​
  • Unified platform through seamless connection between systems​
  • Improved collaboration across clinical and regulatory functions​
  • Improved data quality for regulatory submissions​
  • Validated documentation and processes ensuring GxP compliance​