Electronic Transfer Master Files (eTMF)
The development and implementation of Trial Master File systems are an increasingly important component of a Clinical teams capabilities and require significant business process management changes combined with thorough systems development and implementation planning. The recent focus on non-compliance to TMF regulations by the Health Authorities, as noted by their audit/inspection findings, reinforces the need to improve the TMF process. A tightly integrated eTMF solution of business process management with intelligent systems integration supports and drives the critical trial management processes of Site Start-up essential document collection, site approval and study conduct and will increase compliance to internal SOPS and external regulations
To support your eTMF projects Paragon offers the following solutions:
- eTMF project planning and management
- Business process evaluation, gap and risk analysis
- Optimization of business processes and functional roles
- Systems review, selection, configuration and deployment (from RFI to FRS)
- ETMF project change management and communication planning and execution
- Process and systems training program development and deployment
Trial Master File Transformation