Case Study: Kythera Biopharmaceuticals cuts TMF reconciliation time by 40% and centralizes regulated content with Veeva Systems' Vault

Kythera Chooses Veeva Vault to Manage Regulated Content Enterprise-wide and Shaves TMF Reconciliation Time by 40%

Kythera, a clinical-stage biopharmaceutical focused on facial aesthetics, needed a turnkey system to manage thousands of clinical documents across 26 completed and four active studies. Its legacy patchwork of file shares and SharePoint caused versioning errors, slow study processes, inefficient international document exchange, and required a cloud solution that a small IT team could maintain and update remotely.

Kythera implemented Veeva Vault (eTMF, QualityDocs, MedComms) as a single, cloud-based regulated content platform, enabling real-time document exchange, electronic signatures, integrated reporting, and audit-ready access. The move to a paperless TMF improved workflows and site start-up speeds, reduced errors through version control, and cut TMF reconciliation time by about 40%, while giving teams and auditors secure, anytime access to study documents.

Kythera Biopharmaceuticals

Renee Fate

Senior Manager, Document Management Kythera Biopharmaceuticals