Compliant Migration to Veeva Vault for UK Pharma

Overview

A major UK-based pharmaceutical company faced significant compliance and accessibility challenges with critical trial documents scattered across multiple CRO systems. They partnered with us to execute a large-scale, multi-year migration, successfully consolidating over 80,000 documents into a single, audit-ready Veeva Vault eTMF repository.

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Business Challenge

The client is a major pharmaceutical company headquartered in the United Kingdom. Managing clinical trials often involves collaborating with multiple contract research organizations (CROs), resulting in trial master file (TMF) documents being stored in disparate systems and locations. This presented challenges related to document accessibility, standardization, oversight, and ensuring inspection readiness. The client needed to consolidate these critical documents into their central Veeva Vault Clinical suite (CTMS and eTMF) to improve efficiency and maintain compliance. They required a partner with proven expertise in large-scale, complex Veeva data migrations.

Our Approach and Solution

Structured Migration Methodology

We followed a proven process of detailed data discovery, meticulous mapping of source-to-target attributes, and rigorous testing cycles to prevent data loss.

Expert Business Analysis

Our team worked closely with the client to understand source data structures and align them perfectly with the target Veeva Vault requirements.

Rigorous Data Validation

Following the migration, we employed advanced data verification techniques to confirm the completeness and accuracy of ~80,000 documents, ensuring a trustworthy and reliable repository.

Business and Community Impact

  • Centralized eTMF Repository Established, consolidating approximately 80,000 critical documents from disparate CRO systems into a single source of truth.     
  • Strengthened Compliance and Audit Readiness by ensuring all TMF documents are stored in a standardized, accessible, and inspection-ready system.   
  • Enhanced Document Accessibility, allowing clinical and regulatory teams to search and retrieve essential trial documents quickly.  
  • Enabled Efficient Trial Oversight by providing a unified view of all trial documentation, improving management and decision-making.             
  • Mitigated Risks of Fragmented Data by eliminating the security and compliance vulnerabilities associated with scattered document storage.