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Donawa Lifescience Consulting (DLC) > Contract Research Organization (CRO) > In Vitro Diagnostic (IVD) device clinical areas

In Vitro Diagnostic (IVD) Device Clinical Areas

DLC has significant experience in performance evaluation studies for IVDs. Over the last five years, DLC has managed a large IVD study with over 2,000 subjects enrolled at 12 sites across Europe, US and Canada. Additionally, DLC has provided full clinical services for a smaller study with over 140 subjects enrolled at 3 sites in Europe and US. For both studies DLC regulatory support included the preparation of 510(k) submissions to FDA.

Other performance evaluation studies undertaken by DLC include:

  • Micro-RNA technology
  • Enzyme-linked immunosorbent assay (ELISA)
  • Immuno-turbidimetric assay
  • DNA-based technology
  • End-point assay
  • Coagulation instrumentation
  • Chromogenic method
  • Fluorescent in situ hybridization (FISH) technology
  • Chemiluminescence
  • Microfluidic technology
  • Nucleic acid amplification technologies (NAAT)
  • Plasma inducible nitric oxide synthase (iNOS)
  • Reagents for nucleic acid detection
  • Monitoring disease progress and response to therapy

Please visit the ‘Medical device therapeutic areas’ webpage for information on DLC’s clinical study experience for medical devices.

Please contact us for further information or assistance.