Product

D-TARGET In Vitro Diagnostic Services

March 8, 2012

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)