Post-Market Clinical Follow-Up
Prospective PMCF may be appropriate when predefined clinical information must be collected directly from patients after market introduction.
Prospective PMCF may be appropriate when predefined clinical information must be collected directly from patients after market introduction.
Potential Objectives
- Confirm long-term safety
- Confirm clinical performance
- Evaluate device durability
- Assess reintervention
- Assess revision
- Evaluate quality of life
- Study specific subgroups
- Generate longer follow-up
Bioexcel Support
- Protocol
- Site feasibility
- Investigator selection
- Ethics coordination
- Site initiation
- Recruitment
- Follow-up
- Monitoring
- EDC
- Data management
- Statistics
- PMCF reporting
Can Bioexcel Conduct Prospective PMCF?
Yes. Bioexcel supports prospective PMCF studies from protocol development and site feasibility through recruitment, monitoring, EDC, data management, biostatistics and final PMCF reporting.
