"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."
Getting the right alignment of people, process, and technology supporting a TMF across an organization is incredibly difficult. As the global authority in TMF best practices, Phlexglobal is uniquely positioned to help you achieve and maintain the balance that’s right for you.
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
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
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-CRO Collaboration Module
Reference Model Exchange Mechanism Guidelines