Phlexglobal Clinical Software

Our product offerings are considered highly innovative in the industry for their out-of-the-box best practices capabilities, use of automation technology, and user-focused design.

 

PhlexTMF Software Embeds TMF Best Practices and Advanced AI Technologies Proven in Life Sciences

Phlexglobal is unique among eTMF providers. We leverage dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File—helping you achieve the highest standards for completeness, timeliness, and quality.

PURPOSE-BUILT ETMF TECHNOLOGY

eTMF software designed by the Trial Master File experts specifically for TMF requirements, featuring the industry’s only embedded, configurable TMF Quality Review module. Intuitive design and configurable workflows encourage rapid adoption, while the software’s flexibility and utilization of the TMF Reference Model ensure alignment with your SOPs and best practices.

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PhlexTMF Enterprise

Innovative Trial Master File 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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Bring Order, Stability, and Control to your TMF

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PLANNING & SET UP

PhlexTMF: Purpose-built eTMF software
Phlexglobal’s ‘Gold standard’ best practice TMF configuration
System implementation (standard)
System validation
UAT
User Management
Study set-up  
Pre-built TMF Reference Model structure
Pre-configured user roles
Simple data import (no manipulation)
eLearning user training 
Fixed metadata per sub-artifact
Pre-set workflow
Pre-set milestones  
Pre-set completeness questions  
Advanced configuration options    
Single Sign-On (SSO)    
Live, guided user training    
System integrations    
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MANAGEMENT

Automatic software upgrades
Global support
Pre-built event management  
Read-only viewing for closed studies
Incorporate supplemental studies into a closed study
Manage active studies  
Document upload  
AI-assisted indexing  
Document Quality Control (QC)  
Mobile scanning & classification app (iOS & Android)  
Best-practice query workflow  
TMF Quality Review (QR) module    

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REPORTING

Dashboards (KPIs, quality, completeness, timeliness)   
Quality reports  
Completeness reports  
Timeliness reports  
KPI tracking  
User activity reports  
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CLOSE-OUT

Inspection preparation support
Final completeness report  
Export of final TMF
Final TMF Quality Review (QR)    

Included

Optional

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Latest News

Clinical Trials and the TMF 101 - Blog 1: Basics of a Clinical Trial

Introduction  Firstly, welcome, it is great to see you here. Thank you for taking the time to check out our new blog series on the basics of Clinical Trials and the TMF. This series is designed to be

FDA and MHRA Say Remote and Hybrid Inspections to Continue

At the 2022 Drug Information Association Annual Meeting, held in-person in Chicago June 20-23, representatives from the compliance offices of the FDA and MHRA gave a detailed assessment of the pros

Examining the Why and How of Integrating Your eTMF and CTMS

Adapted from a Phlexglobal Ask An Expert interactive discussion held May 11, 2022 and available on-demand here.   Why Integrate Your CTMS and eTMF Systems?  A typical electronic Trial Master File

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It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
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