About Us

Can your CRO say this?

  • DXOCRO is the leading contract research organization (CRO) specializing in the commercialization of diagnostic biomarker technologies.
  • DXOCRO's staff has assisted in over 120 of the most challenging FDA IVD clinical trials, including many of the Class III approvals of IVD products.
  • DXOCRO is well-respected for our expertise in navigating the waters of the most difficult and largest clinical trials in the IVD industry.
  • DXOCRO's services include strategic consulting, specimen acquisition, laboratory testing, and regulatory consulting.
  • DXOCRO is an expert provider of Contract Services to IVD test developers, manufacturers and laboratories providing Laboratory Developed Tests (LDTs).

Expertise

  • Regulatory Strategy Expertise
  • FDA Negotiation
  • Clinical Trial Protocol Development
  • Clinical Site Recruitment
  • Clinical Trial Management
  • Statistical Planning and Analysis
  • Final Clinical Trial Reports
  • Regulatory Submissions    
  • Quality System Design and Audits
  • ISO 13485:2016 Compliant