Why Do CROs Require a Standardised eTMF?
Clinical trials involving multiple CROs operate across different TMF structures, systems, and SOPs. A standardised eTMF brings all CROs under one controlled framework (same structure, classification, and workflows), enabling real-time completeness tracking, continuous sponsor oversight, and consistent inspection readiness throughout the study lifecycle.
How AQ eISF and ePSF Support Multi-Site Documentation Governance Across a CRDC Network?
A CRDC research network distributes clinical trial delivery across multiple NHS sites while concentrating governance accountability at the hub. AQ eISF and ePSF are built to give the hub that control: connecting site documentation, pharmacy accountability, and quality governance into one inspection-ready operating layer across every participating site. Key Takeaways: The Documentation Control Problem Specific […]
What is ePSF in Clinical Trial Data Management?
An Electronic Pharmacy Site File (ePSF) is a digital repository, designed to support 21 CFR Part 11 requirements, 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 […]
CTMS vs eTMF: What Is the Difference?
A CTMS runs a clinical trial while it is happening. An eTMF holds the evidence that it happened that way, for 25 years after the trial concludes under the amended UK regulations. This guide compares the two on retention, structure and inspection, and gives six questions that route any record to the right system.
What is an eTMF in Clinical Trial Research?
eTMF (electronic Trial Master File) stands as one of the most important clinical research software systems. It enables structured management of clinical trial documentation in alignment with ICH GCP, FDA 21 CFR Part 11, EU Annex 11, and the TMF Reference Model. AQ eTMF is the trial master file module within the AQ Platform. Clinical […]
What is eISF: Electronic Investigator Site File in Clinical Research
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with one structured place where teams can upload, review, and track documents while ensuring nothing is missing, outdated, or unapproved.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 eISF is the […]
