Leveraging our decades of experience, we design and deliver a TMF and clinical data management plan that ensures high-caliber and complete study documentation.
From design to implementation, Advanced Clinical’s experienced clinical Document Management team combines clinical trial expertise and technical know-how to ensure a high-quality and complete eTMF and clinical document management system for any study.
At Advanced Clinical, flexibility is our strength. We can operate within multiple systems to accommodate your unique requirements and ensure operational efficiencies by using only the most advanced, cloud-based and integrated solutions.
Our TMF Experts Support a Variety of Initiatives, Including:
- End-to-End Active TMF Management
- eTMF Implementation and Support
- eTMF System Administration
- TMF Migration Execution
- Process Development
- TMF Governance and Quality Assessments
Active TMF Management
End-to-end TMF management and support, from TMF set up to closeout and transfer of final TMF or long-term archival
Implementation support for sponsor-owned eTMF systems, including design, testing, training and deployment
eTMF System Administration
Ongoing, active support of sponsor-owned eTMF systems at a system administration level, including dashboard development and user account management
Paper to TMF, eTMF to eTMF, other system to eTMF full migration support and conduct, from planning to execution
Creation of TMF SOPs and work instructions, a regulatory document management system, templates for TMF Plans and TMF Indexes, training materials and relevant guidance docs as needed
Governance and Quality Assessments
Process optimization, KPI development, inspection readiness preparation and support and overall quality assessments of the TMF