Veeva Implementation For a top-30 EU-based Pharma Company
Problem
A top biopharmaceutical EU-based company decided to transition from the Argus Safety to the Veeva Safety Vault platform. The implementation scope is Vault Safety, Signal Detection & Management, Workbench, Integrations, and Validation. The key challenges include:
- Complex data migration involving millions of records and documents
- Ensuring data integrity across product and license information
- Coordinating across multiple vendors and internal teams
- Harmonizing disparate processes and training the users on the new system
- Adoption of the new “early adopter” tools including Workbench and Signal
Solution
ELIQUENT and Pinnaxis are managing the entire program and workstreams, delivering a comprehensive solution tailored to the client’s needs.
- Workstream-Based Execution: Multiple dedicated workstreams covering ICSR Process and Training, ICSR Configuration, ICSR and Signals Data Migration, Signal Management Process and Training, Signal Management Configuration, Reporting, Validation, and Program Management
- Process Optimization: Conduct fit-gap assessments, redesign workshops for ICSR and Signal processes, develop harmonized SOPs, and train end-users. Quickly ramped up to the new tools to provide configuration and process support.
- Configuration & Validation: Developed configuration for Veeva Safety Vault & Signal, including user story development, collaborating with Veeva
- Data Migration: Migrating ICSR and Signal data from Argus and PV signal, using a proven migration tool and executing multiple dry runs to ensure accuracy
- Reporting: Writing reporting requirements for platform and Workbench reports, including tech specifications, and collaborating with the Veeva report development team on testing and feedback
- Collaboration Model: Embedded our SMEs within each workstream, coordinated with Veeva configuration leads, and ensured alignment with the client stakeholders
- Phase-2 (Japan roll-out) analysis: Process and data analysis and mapping (Perceive) for phase-2, which is planned to kick off in Q3 2026
Expected Results
- Program Management: The only large-scale Veeva deployment executed under a single point of accountability delivered by a unified, end-to-end project team
- Data Migration: About 1 million cases and millions of documents to be successfully migrated to Veeva Safety Vault
- Improved Efficiency: Streamlined ICSR processes, with reduced follow-up forms and clearer workflows
- Early Adopter Product Improvements: Direct feedback for “new” products based on workstream outputs and testing