Case Study: OM Pharma achieves 40%+ improvement in TMF completeness and stronger inspection readiness with Veeva Systems' Vault eTMF

How OM Pharma Drives TMF Inspection Readiness With a Lean Team

OM Pharma, a Geneva-based biotech with about 500 employees running five clinical trials (Phase I–IV), relied on a small clinical operations team and SharePoint for document storage—an approach that left them ill-prepared for regulator expectations of a standalone, fully auditable eTMF. This created completeness gaps and inspection-readiness risk across multi-country studies and CRO collaborations.

The company implemented Veeva Vault eTMF and a hybrid governance model (shared or aligned CRO Vaults), and adopted collaborative authoring, expected document lists, dashboards, and targeted retraining. These changes improved TMF completeness by more than 40% in three months, reduced risk, increased productivity and sponsor visibility, and set the stage for further automation (TMF Bot and seamless transfer) to sustain inspection readiness.

OM Pharma

Nelson Da Silva

eTMF Specialist and Clinical Trial Associate Lead