Clinical study design
- Provide input on site selection, inclusion/exclusion criteria, etc.
- Provided input on optimal sample type and collection procedures
Patient enrollment and sample collection
- Develop patient enrollment and retention (if applicable) plans
- Provide on site training and monitoring of sample collection
- Determine sample transit and storage logistics
Clinical data management
- Build clinical data base and perform biostatistical analysis
- Combining clinical outcome with analytical data to determine clinical validity and utility of Dx test
- Build algorithms for multiplex tests if applicable
Regulatory submission (European and US)
- Strategic regulatory plans – understanding the road to market
- Investigational device (IDE) submissions
- Pre-market approval (PMAs) applications and pre-market notification submissions (510k’s)