For over three decades, MDC has been the Clinical Research Organization (CRO) partner of choice for diagnostic innovators, guiding companies through the regulatory and clinical hurdles to bring critical tests to market. We help companies anticipate the challenges, understand the strict regulations, and develop clinical studies fit to purpose with zero tolerance for error.

That is why we identify obstacles early, minimize risks with pristine execution, and guide companies through the essential steps to market authorization. Whether a client requires clinical, regulatory, or quality support, we provide tailored solutions to meet their needs.
We achieve this by seamlessly integrating with the client’s team, providing senior-level expertise precisely when and where needed. Every engagement is tailored to the project’s goals, budget, and timeline.

Our results speak for themselves. We have delivered over 150 successful FDA submissions and managed more than 100 clinical studies across a wide variety of diagnostic areas. Our experience spans diagnostic tests located in the central lab or near patient at point of care or at home testing. Combined with our strong industry relationships and collaborative culture, MDC provides the confidence and clarity you need to reach the market efficiently.