What is a CDO?

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A Contract Diagnostics Organization (CDO)  allows diagnostic, biotechnology and pharmaceutical companies to outsource to a single partner offering integrated services within one organization. ResearchDx combines diagnostics research, a licensed and accredited clinical laboratory, manufacturing, and consulting, in an integrated, technology-independent manner.

 

ResearchDx can design, manage, and coordinate all aspects in the development of a diagnostic product. Our services include: (1) Assay development, platform evaluation and validation; 2) Management of all levels of regulatory compliance, processes, applications and approvals, including FDA submissions for 510(k) or Premarket Approval (PMA) clearances; 3) CLIA approved and CAP accredited Clinical Laboratory services and 4) GMP manufacturing services.