AI SUGGESTIONS AT UPLOAD
Prevent document filing errors before they occur with suggestions based on millions of documents and the embedded guidance of TMF experts - immediately improving TMF quality and reducing inspection risk
TMF QUALITY REVIEW
PhlexTMF Quality Review tools let you quickly and easily conduct regular, risk-based, or milestone-driven completeness reviews.
Integrated and intuitive iOS and Android app makes filing documents simple and convenient, scanning and classifying documents by artifact and uploading them directly to PhlexTMF.
INTUITIVE USER INTERFACE
A simple interface with a unique combination of tree and search navigation which offers flexible document location options which are preferred by auditors and inspectors.
SIIMPLIFIED STUDY SETUP
Capture what is unique about a trial with study setup questions to address specific trial parameters and document requirements while still enforcing filing standards across the organization.
Easily and visually identify missing documents with views that show documents received versus expected in real-time across trial, country, site, zone, vendor, and other parameters.
eTMF EVENT MANAGEMENT
Capture study changes such as protocol amendments that affect expected documents, plus track collection and quality control event stories to verify completion.
Define where documents are expected which drives completeness metrics; simplify uploads by removing the need to fill in numerous fields for every document.
Flexible workflows help designate the path of a document from upload to inspection readiness.
OVERSIGHT & REPORTING
dynamically filter results and can use heatmap visualization to show TMF timeliness and quality.
eQUERY TRACKING SYSTEM
Identify, communicate and track remediation of TMF issues, eliminating multiple communication paths and capturing all relevant information in one place.
Easy transportability of your TMF between organizations and systems in the Exchange Mechanism format, ensuring order to the interchange of your TMF content, metadata, audit trail and electronic signature information.
Much more than transactional eTMF software, with PhlexTMF you also gain a comprehensive TMF management system with executive overview, pragmatic visibility for study owners, and embedded TMF intelligence that:
The Shoulds and Shouldn’ts of Electronic Systems and Data in Clinical Trials Intro With the word should being mentioned 569 times and constituting ~7% of the content (only outweighed by data – 618
Trial master file misfiles are a common occurrence, with as many as one in every 10 documents being misfiled. In some ways, misfiles are an even greater issue now with eTMF systems, where filing is
Introduction Well, first and foremost, welcome! Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those