Trial Documentation

An Electronic Pharmacy Site File (ePSF) is a Part 11–compliant digital repository within a Clinical Trial Management System (CTMS) that manages investigational product documentation, pharmacy records, and accountability data across clinical trials. It standardises how pharmacy-controlled records are created, organised, authorised, and audited in alignment with ICH-GCP requirements. In simple terms, ePSF works as the […]

Industry Discussions AQ Notably, an eISF is a digital system that keeps all site documents organised, up to date, and ready for review throughout a clinical trial. It replaces paper binders and scattered folders with one structured place where teams can upload, review, and track documents while ensuring nothing is missing, outdated, or unapproved. AQ’s