Case Study: Praxis Precision Medicines achieves an 84% reduction in TMF migration prep time with Veeva Systems' Vault eTMF

Praxis Eliminates Manual TMF Migrations and Reduces Transfer Prep Time by 84%

Praxis Precision Medicines, a Boston-based clinical-stage biopharma, faced cumbersome TMF management after outsourcing to multiple CROs. Inconsistent systems meant document-by-document reviews, long end-of-study migrations, and lengthy preparation times—up to 25 days—making oversight, standardization, and inspection readiness difficult for the small internal team.

Praxis brought TMF in-house using Veeva Vault eTMF (with Vault RIM and QualityDocs), invited CROs to work directly in its system, and automated transfers and classification with TMF Transfer and the TMF Bot while applying risk-based QC. The three-person TMF team cut migration prep from 25 days to four (an 84% decrease), reduced closeout staffing from three people to one, shortened final TMF receipt timelines by about three months, and eliminated manual review of listings and audit trails.

Praxis

Katie Kelly

Associate Director of Clinical Study Operations