PhlexTMF: Next Generation eTMF

Industry's only complete eTMF solution with AI capabilities ready on Day One to improve TMF quality and reduce inspection risk

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PHLEXGLOBAL ANNOUNCES INDUSTRY-FIRST eTMF AI THAT REDUCES RISK OF DOCUMENT MISFILES AND METADATA ERRORS TO IMPROVE TMF QUALITY AND INSPECTION-READINESS. Read more

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PhlexTMF from Phlexglobal - DRIVEN BY CUSTOMERS, BUILT BY THE TMF AUTHORITY

Ensure your Trial Master File is complete, timely, and accurate at all stages of a trial and across the document lifecycle with PhlexTMF, eTMF software dedicated 100% to TMF best practices. PhlexTMF offers the industry's only pre-trained AI solution that reduces document misfiles and metadata errors at the critical document upload step - immediately improving TMF quality and reducing inspection risk.

Unlike eClinical “platforms” or generic electronic content management systems built for other industries, Phlexglobal leverages our extensive TMF expertise and innovation to developing customer-driven, purpose-built eTMF technology with embedded best practices.
Phlexglobal's team of global TMF practitioners, quality management professionals, and technologies build customer-driven insight into innovative eTMF software. The result? You obtain authoritative, real-time intelligence and management control regarding completeness, timeliness, and quality of your TMF - whether internal or outsourced to a CRO - with the ability to easily identify gaps and take corrective action.

See how next-generation AI improves the speed and accuracy of document filing

Key PhlexTMF Features & Benefits

AI-Assisted Indexing

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

TMF QUALITY REVIEW
PhlexTMF Quality Review tools let you quickly and easily conduct regular, risk-based, or milestone-driven completeness reviews.

Mobile App

MOBILE APP
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.

Intuative User Interface

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.

Simplified Study Setup

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.

Wizard Driven Completeness

WIZARD-DRIVEN COMPLETENESS
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 Managment

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.

Intelligent Placeholders

INTELLIGENT PLACEHOLDERS
Define where documents are expected which drives completeness metrics; simplify uploads by removing the need to fill in numerous fields for every document.

Process Management

PROCESS MANAGEMENT
Flexible workflows help designate the path of a document from upload to inspection readiness.

Oversight and Reporting

OVERSIGHT & REPORTING
User-configured dashboards
dynamically filter results and can use heatmap visualization to show TMF timeliness and quality.

eQuery Tracking System

eQUERY TRACKING SYSTEM
Identify, communicate and track remediation of TMF issues, eliminating multiple communication paths and capturing all relevant information in one place.

Self Service Archiving

TMF EXPORTING
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:

  • Provides a complete solution for managing TMF processes throughout the study lifecycle, from initial planning and study startup to closeout, inspection, and final archive
  • Embeds TMF best practices in an intuitive design so that you and your team can master the software quickly and easily, getting business value from day one
  • Allows for easy configuration of the software to align with your own workflows and best practices, or to embed more efficient workflows due to organizational improvements
  • Delivers a steady cadence of software releases incorporating industry-driven TMF best practices, while leveraging business-enabling technology advances such as machine learning and natural language processing (NLP)
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PhlexTMF Enterprise

Innovative TMF management for higher quality output via automation.

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PhlexTMF
Express 

Improve inspection-readiness faster with software built on TMF best-practices.

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PhlexTMF
For Viewing

Viewable, inspectable eTMF archive for closed studies from your CRO.

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PhlexTMF
For CROs

Give your customers the confidence of TMF Health from plan to archive.

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PhlexTMF
For MedTech

Streamline your approval pathways including MDR and FDA Clearance

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Do you need help in deciding which platform is best for you? Download our decision guide here
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