All Diagnostic Resources Under One Roof

What is a CDO-researchdx

As a Contract Diagnostic Organization (CDO), we’re a single partner solution for your companion diagnostics and IVD development needs. We’re a one-stop IVD shop — a unique arrangement in today’s diagnostics outsourcing industry.

A CDO integrates biomarker research, a fully-licensed and accredited clinical molecular laboratory, quality and regulatory, consulting and manufacturing all under the same roof. Traditionally, a pharmaceutical company seeking to develop a companion diagnostic must contract multiple vendors to meet these needs in the development process. The inherent complexity of managing and communicating with multiple vendors renders a process that is neither efficient nor flexible, particularly when unexpected priorities or challenges are encountered. Importantly, no bias is introduced as occurs with a diagnostics company that develops IVDs using only their proprietary technologies and platforms. Our CDO is not tied to any technology or platform manufacturer—we explore the best technology fit for the application or purpose.

By integrating all diagnostics services under the same roof, our biopharmaceutical and diagnostic clients experience a simplified, dynamic and adaptive process during the development pathway. An IVD and new drug can be synergistically developed in parallel with matching timelines for FDA approval and market launch.

Biopharmaceutical and diagnostics consulting services are part of what we do as a CDO. Examples include all elements of regulatory compliance—processes, applications, approvals and FDA interface; Technology Assessments (TA) including patentability; set-up and maintenance of a CLIA-certified laboratory. Check out our Services and Capabilities below.

CRO vs CDO

Contract Research Organizations (CRO) are traditional and well-established outsourcing options for pharmaceutical clinical research. Their focus and expertise lies in clinical strategy and operational efficiency for pharmaceutical clinical trials. A CRO differs greatly from a CDO in that it is not an IVD diagnostics development or manufacturing resource nor do they operate certified clinical laboratories. A CRO is a valuable resource for a pharmaceutical company seeking to outsource all drug clinical trial activities. A CDO is a valuable resource for all IVD development activities, biomarker discovery, and IVD clinical trials through regulatory approval.

Diagnostics Companies vs CDO

Larger diagnostic companies offer partnership opportunities to pharmaceutical companies to develop IVDs based their proprietary technologies or platforms. It’s an advantageous market opportunity both ways as the pharmaceutical company has a way to market their test immediately and the diagnostics company can add a new test to augment their technology or platform menu. However, there is a missed opportunity that occurs in the development process when the bias of assessing only one technology is introduced—there is no “best fit for purpose evaluation”. In the case of the CDO who is not tethered to a specific manufacturer, a CDO becomes the technology and platform agnostic choice. The focus for most large diagnostic companies is to build their proprietary product portfolios and offerings whereas the focus for a CDO is to provide complete and independent diagnostic services and consulting supported by a federal and state credentialed clinical molecular laboratory for all testing.

Find Out More About ResearchDx CDO Services and Capabilities

Contact us to set up a consultation about your project needs.