Put Your Trust In The Global TMF Experts

Embed industry-proven TMF best practices in your organization

"Phlexglobal’s strengths are its expertise, its knowledge of legislation, knowing what the inspector wants, and how clinical teams interact. They are embedded industry experts."

Director, Business Operations
Top 20 Pharmaceutical Company


What is the secret to ongoing TMF health? Technology? Training? Outsourcing? The right SOPs?

Over the course of hundreds of successful TMF customer engagements, Phlexglobal has achieved an unmatched level of insight into what drives TMF success. That is why we know the correct answer to the above questions is “all of the above, and more – and in the right measure."


Our expert TMF consultants help your company reach and hold onto this TMF “Health Zone” by:

  • Extending proven TMF methodologies and best practices to your organization, improving your business practices and workflows to achieve mastery over the administration and management of your documentation and data
  • Guiding you through the successful development and implementation of strategic or tactical TMF-related initiatives such as active management, new or refined SOPs, TMF migrations, improved document management and workflows, or more effective CRO oversight
  • Streamlining TMF-related operations to increase efficiency, productivity, and regulatory compliance – and freeing up valuable internal TMF resources to do more with less
  • Improving communication and collaboration with internal stakeholders and external providers, maximizing TMF quality and timeliness while increasing user acceptance and compliance

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Gain Expert Guidance Across the TMF Lifecycle

Phlexglobal’s hand-on experience informs our best practices approach to the entire TMF lifecycle, facilitating planning, compliance, and knowledge management.

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TMF Analysis

Current TMF Assessment

TMF Structure Definition

TMF Scoping and Implementation

Metadata Assessment

QC Processes

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eTMF Technology

eTMF Requirements, Selection, and Implementation

Analysis of Legacy Systems and File Structures

Data Integration and Integrity

eTMF Implementation Best Practices

Assessment of TMF-Dependent Systems

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Business Processes Review

Policy, SOP, and Process Reviews

Embedding Proactive TMF Culture

Change Management Planning

Role and Responsibilities Definition

Cross-Functional Alignments. 

Regulatory Compliance

Regulatory Compliance

GCP Inspection-Readiness: FDA, EMA, PMDA, MHRA, CFDA and more

Audit Preparedness e.g. Audit Trails vs. Activity Logs; Traceability

Records Management Policies

Sponsor & Site Archiving and Storage 

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Sponsor/CRO Management

Choosing a CRO

Governance and Oversight

Communication and Collaboration Best Practices: Getting to Alignment

Roles and Responsibilities Definition

Managing Protocol Amendments 

TMF Reference Model

TMF Reference Model

TMF Reference Model Workshops

Sponsor Module

CRO Module

Sponsor-CRO Collaboration Module

Reference Model Exchange Mechanism Guidelines 

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It's time to raise your standard 

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Latest News

A Blueprint for Genuine Partnership in TMF Improvement

The Trial Master File (TMF) has evolved from a repository of documents at the end of a study to an integral cog in the regulatory journey. This has led some companies to shift their perspective from

Rewind the clock and take TMF back to basics

Rewind the clock and take TMF back to basics: The paradigm of maintaining simplicity while embracing technology. In 20 years, the Trial Master File (TMF) has moved from paper in dusty lever arch

How to Reduce Risk and Effort When Migrating a Trial Master File

Migrating Trial Master File (TMF) data is a fairly common occurrence, usually driven by one or more of the following scenarios: Implementing a new electronic Trial Master File (eTMF) system