From Sample Strategy to Clinical Performance Evidence.
Bioexcel supports IVD manufacturers with clinical performance studies, prospective and archived sample programs, reference testing coordination, intended-user studies, data management, biostatistics, performance evaluation and post-market performance evidence.
Where Does Your IVD Program Need Support?
Select the support area that matches your clinical development, safety, data or submission needs.
Need support across multiple functions?
We can build an integrated scope around your development program.
What Bioexcel Provides
Integrated clinical and regulatory support across the complete ivd & diagnostics evidence lifecycle.
Strategy
Clinical Performance
- CPSP / protocol
- Site and sample feasibility
- Index device testing
- Reference method
- Monitoring
- CPSR
Execution
Biometrics
- EDC
- Diagnostic data management
- Sensitivity / specificity
- PPA / NPA
- Confidence intervals
- Discordance analysis
Lifecycle
Performance Evaluation
- Scientific validity
- Analytical performance integration
- Clinical performance
- PMPF
Where Bioexcel Has Experience
Clinical and regulatory experience across ivd & diagnostics technologies.
How a Program Moves Forward
A connected pathway from evidence strategy to lifecycle management.
PHASE 01
PLAN
Define the strategy and plan for success.
PHASE 02
EXECUTE
Execute with precision and ensure integrity.
PHASE 03
DELIVER
Deliver evidence that drives decisions.
One connected team. One evidence pathway.
Share your product, current evidence status, target market and program objective with Bioexcel. Our team can help define the next evidence step.