Case Study: UroGen Pharma achieves streamlined clinical and regulatory operations with Veeva Systems' Vault Clinical-to-RIM Connection

UroGen Streamlines Clinical and Regulatory Operations

UroGen, a Princeton-based biopharma focused on urology and uro‑oncology, faced slow, error‑prone workflows because clinical and regulatory teams stored documents in separate Vault RIM and Vault Clinical Operations systems. Cross‑functional tasks like preparing IND updates required manual downloads, uploads, and spreadsheet tracking, leading to duplicate files and risk of omissions.

UroGen implemented the Vault Clinical Operations to RIM Connection to automatically synchronize documents and data between systems—for example, sharing approved trial records to Vault Submissions and protocol changes to Vault eTMF. The integration created a single source of truth, eliminated manual transfers, improved visibility and document quality, and sped clinical and regulatory processes just in time to support its first global phase‑three trial, with plans to expand the connection to more document types and processes.

UroGen Pharma

Dominick Gagliostro

Senior Director of Project Management and Regulatory Operations