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."
Our expert TMF consultants help your company reach and hold onto this TMF “Health Zone” by:
Current TMF Assessment
TMF Structure Definition
TMF Scoping and Implementation
Metadata Assessment
QC Processes
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
Policy, SOP, and Process Reviews
Embedding Proactive TMF Culture
Change Management Planning
Role and Responsibilities Definition
Cross-Functional Alignments.
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
Choosing a CRO
Governance and Oversight
Communication and Collaboration Best Practices: Getting to Alignment
Roles and Responsibilities Definition
Managing Protocol Amendments
TMF Reference Model Workshops
Sponsor Module
CRO Module
Sponsor-CRO Collaboration Module
Reference Model Exchange Mechanism Guidelines
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: The paradigm of maintaining simplicity while embracing technology. In 20 years, the Trial Master File (TMF) has moved from paper in dusty lever arch
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
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