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Holistic TMF health assessment
At Cencora, our industry experts provide a comprehensive review and assessment of your people, processes, technology, and organization's strategy, ensuring the overall health of your Trial Master File (TMF).
Our workstreams
People
People are the driving force behind a successful TMF strategy. Every organization needs individuals who are not only trained to perform their roles effectively but also committed to promoting TMF health at every stage. By ensuring that team members possess the necessary skills, organizations can enhance data integrity and compliance, ultimately leading to improved outcomes.
Process
An efficient end-to-end process is crucial for the success of any project, and the TMF is no exception. Without such a process, projects often face delays, inconsistencies, and compliance issues, ultimately leading to failure. At Cencora, we leverage our extensive experience and expertise to ensure the success of your TMF through a focused approach on five key areas: set up, timeliness, quality, completeness, and closeout.
Technology
While technology plays a crucial role in managing and storing TMF documents, it cannot guarantee a successful TMF strategy on its own. The electronic Trial Master File (eTMF) is an integral component of your overall strategy and should be treated as such. To advance effectively, it is essential to review workflows, assess metrics capabilities, and explore relevant use cases, as these elements are pivotal in optimizing the eTMF's impact and ensuring a robust TMF management process.
Example customer inputs
Inspection or audit findings
eTMF system requirements
eTMF training collateral
SOPs and work instructions
KPIs and metrics
TMF health oversight
Our approach
People
Review scope for key TMF contributors
- Survey of all key users and contributors
- Conduct virtual interviews to understand what is and isn’t working
- Review format/content of existing TMF training courses and assessments provided to users for completion
Process
Review existing technical documents
- TMF operating model: sponsor, CRO, and vendors
- Inspection-readiness
- TMF setup, maintenance, closure, and archiving
- TMF content stored outside of the TMF system
- TMF health leveraging metrics
- Governance leveraging metrics
Technology
Review existing system configuration
- Approach for measuring timeliness, completeness, and quality of your TMF
- Content workflows
- System integrations
- Unblinding content
- Metadata management
- Self-serve reporting/dashboard capabilities
Summary report and next steps
Oversight model
Education and training
Technical writing
eTMF system configuration
Dedicated TMF services
Connect with our TMF experts to learn more
Get in touch to learn about how our solutions can help accelerate better health outcomes. Whether you have questions or just need more information, our experts are here to assist you.