Put Your Trust In The Global TMF Experts

Embed industry-proven TMF best practices in your organization

TMF Expert Consulting

Create immediate and lasting improvements in your TMF business processes

"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."

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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 

CONTACT PHLEXGLOBAL TODAY
 
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Latest News

Smart Steps to Managing Your TMF Audit Trail

The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,

Lowering the TMF temperature through quality reviews

We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts

Five-step Game Plan for a TMF Close-out

Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or