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Home » products » D-TARGET In Vitro Diagnostic Services


D-TARGET In Vitro Diagnostic Services

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)