Case Study: Criterium Inc. achieves centralized, compliant trial document management with Montrium’s eTMF Connect

Criterium Inc. - Customer Case Study

Criterium Inc., a full-service contract research organization based in Saratoga Springs, New York, was struggling with a hybrid fileshare-and-paper TMF that required extensive Excel-based trackers to reconcile documents, measure study metrics and support growth. To modernize and scale their operations, Criterium selected Montrium’s eTMF solution, eTMF Connect, for a more user-friendly, validated electronic trial master file.

Montrium implemented eTMF Connect, managing migration, training and configuration to deliver a centralized, compliant system (including permissions and e-signatures meeting 21 CFR Part 11). The change eliminated external trackers and file shipping, enabled rapid filing and one-click export of thousands of documents, provided real-time visibility of expected/incomplete/overdue items, improved collaboration with sponsors and sites, shortened approval cycles, and helped Criterium onboard new studies more efficiently.

Criterium Inc.

Nicole Palmer

Clinical Trial Administrator Manager