Key Features/Benefits

Maintains visibility, status and control of trial documentation

Improves readiness for audits and inspections

Enables faster and more efficient site setup and initiation

Ensures file structure and organization quality with support for the DIA TMF Reference model

Delivers significant time and labor cost savings compared to paper-based TMF approach

Streamlines key business processes through integrated workflows

Enables easy search, retrieval, reporting and status overview of documents

Fully integrated with CTMS and investigator portal solutions

Background

Providing controlled access – storing, organizing and tracking — to thousands of essential clinical trial documents is no easy task. The time and labor-intensive method of using paper-based or file-share based electronic file cabinets and Excel spreadsheets to manage the Trial Master File (TMF) is giving way to electronic, cloud-based TMF solutions that help meet GCP regulatory requirements, all while lowering costs and expediting critical process steps such as the setup of sites.

agFileMaster™

agFileMaster™ serves as the centralized, global repository for managing, organizing, storing, accessing and archiving all trial-related documents.  It is fully validated, 21 CFR Part 11 compliant and helps to ensure readiness for audits and inspections. Complete sponsor and investigator files including list of all expected and required documents can be rapidly created for each study.  For fast, easy setup of the TMF, agFileMaster™ allows companies to define multiple TMF templates so the study manager can select the appropriate template and modify it to any study’s specific needs.

Full document management is combined with clinical trial logic to support the complete lifecycle of each document.  Authors can upload new documents and start a workflow-driven, review-and-approval process.  Context-sensitive document management capabilities manage, present and store documents according to their relations to clinical operations contexts to support trial management processes such as identifying required documents in the green light process.

agFileMaster™ retrieves documents rapidly using powerful search criteria that enable rapid access to documents in the system, regardless of the status.  agFileMaster™ integrates out of the box with agClinical and agCenter, helping clinical operations teams reduce data-entry efforts and ensure the consistency of data in a way that stand-alone applications cannot offer

Electronic Trial Master File (eTMF)

clinical safety solution software