PhlexTMF+ Full-Service Trial Master File Management

The Industry’s Only Turnkey, End-to-End TMF Outsourcing Solution from a Single Expert Provider

Get TMF Compliance Peace of Mind with Less Effort

PhlexTMF+ includes all components required for ongoing TMF health, managed by the global authority in Trial Master File best practices - providing ongoing inspection-readiness while freeing internal resources for critical study tasks.

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See what PhlexTMF+ Can Do for You

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Complete TMF Management at Every Stage

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Planning & Set Up

  • PhlexTMF Advanced eTMF
  • Software
  • Reference Model TMF Structure
  • Best Practice SOPs & Workflows
  • TMF Roles
  • Query Setup
  • System Training
  • Company SME Training
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Management

  • Document Processing
  • AI-Assisted Indexing
  • Quality Control (QC)
  • Ongoing Quality Oversight
  • Project & Query Management
  • Global Support
  • User Management
  • System & Infrastructure Upgrades
  • Wide Variety of File Formats
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  • Completeness Assessment
  • (inspection-readiness)
  • Secure Short-Term Storage
  • Inspection/Audit Support
  • Final TMF Export
  • Long-Term Archiving
  • Consultation

 

Not sure what you need?
See our PhlexTMF+ plan comparison or download our TMF Outsourcing decision guide. 

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PhlexTMF+ Helps Organizations...

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IMPROVE TMF HEALTH

  • Leverage unmatched, global TMF expertise to reduce risk of inspection findings and submission delays
  • Optimize all aspects of TMF management critical to ongoing TMF health across people, process, and technology
  • Take advantage of the latest TMF management best practices such as risk-based QC, ongoing quality review, and completeness heatmaps
  • Quickly bring on the expert resources you need to manage TMF management demands, with the ability to scale to any volume

 
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REDUCE EFFORT & RISK

  • Benefit from advanced technologies that improve TMF management speed and quality, including artificial intelligence 
  • Obtain budget predictability with a fixed-price model encompassing best-of-breed eTMF software, infrastructure, and expert services critical to ongoing TMF health
  • Free key internal resources from time-consuming tasks such as document filing and indexing, software management, and query management
  • Eliminate potential delays through earlier identification and correction of issues around quality, completeness, and timeliness of your Trial Master File

Wondering if Full-Service TMF Management is Right for your Organization? 

Download the Decision Guide "What to Know Before You Outsource Your Trial Master File"

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The guide includes pragmatic advice including:

  • Why Outsource Your Trial Master File
  • How to Determine Which TMF Outsourcing Model Is Right for Your Organization
  • Questions to Assess Your Current People, Process, and Technology Capabilities Based On TMF Management Best Practices
  • TMF Outsourcing Decision Grid: Mapping Your Current TMF Management Capabilities to Industry Benchmarks
  • Key Requirements for TMF Management Service Providers
  • Provider / Provider Subcontractor Attributes
  • Requirements Checklist: Full-Service TMF Management

Get the Guide

A Full Service Plan with Options

Find the model that best fits your situation

 

  

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Preconfigured Software +
Expert TMF Management

PhlexTMF+ Enterprise Logo

Configurable Software +
Expert TMF Management
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PLANNING & SET UP

 PhlexTMF: Phlexglobal’s purpose-built, expert eTMF software Plus Plus
Phlexglobal’s ‘Gold standard’ best practices configuration, processes, and services Plus Plus
TMF Reference Model structure Plus Plus
Predictable fixed-fee pricing Plus Plus
eLearning training for users Plus Plus
Live, guided user training   Plus
Multi-study pricing   Plus
Implementation fees   Plus
Dedicated environment   Plus
Configurable software, processes, and services   Plus
Test & production environments   Plus
Additional non-production environments   Plus
Long-term agreement with shared risk fees   Plus
       

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MANAGEMENT

 User Management & Study set-up Plus Plus
Digital document processing Plus Plus
AI-assisted indexing Plus Plus
Quality Control (QC) Plus Plus
Query setup & management Plus Plus
Global support Plus Plus
Ability to easily upgrade to next tier w/preferred pricing Plus Plus
Software upgrades Plus Plus
Expert regulatory compliance consulting Plus Plus
Paper document processing   Plus
       
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CLOSE OUT

 Secure short-term TMF storage within PhlexTMF Plus Plus
Export of Final TMF Plus Plus
Completeness Reporting Plus Plus
Audit & inspection support   Plus
TMF Quality Review OPTIONAL OPTIONAL

 

Request a Consultation

Infographic - PhlexTMF+ Full-Service TMF Management

See it in more detail

Download the PhlexTMF+ Infographic to see how to simplify compliance while delivering Ongoing TMF Health

 

Get the Infographic

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Want to see it in action? 

Request a Free Demo
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Get the Details - Download the PhlexTMF+ Data Sheet! 

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It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
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