A Boutique CRO Specializing in IVD and Medical Device Clinical Research

Welcome to CovarsaDx, your trusted partner for in vitro diagnostic (IVD) and medical device clinical research. At CovarsaDx, we specialize exclusively in clinical trials for diagnostic and device products, making us different from traditional, generalist contract research organizations (CROs).

If you’re looking for a clinical research partner with the agility and insight to guide your investigational tests to market, you’ve come to the right place.

Why CovarsaDx?

We approach IVD and medical device trials differently—because this is all we do. Unlike large CROs that may have a small department for diagnostics, CovarsaDx is built entirely around the needs of IVD and medical device innovators. Every advisor on our team is a dedicated specialist with deep experience designing, managing, and executing regulatory-grade clinical studies.

Our boutique approach gives clients direct access to senior experts who can anticipate challenges and strategically navigate complex trial landscapes. From early feasibility through pivotal trials, we offer customized clinical research strategies backed by a robust network of experienced investigators and top-tier clinical sites.

Our Commitment to Regulatory Success

As an independent CRO, CovarsaDx is known for its responsiveness, adaptability, and proven ability to deliver high-quality data that stands up to regulatory scrutiny. Our team closely monitors changes in the global regulatory environment, ensuring that every study is designed for submission success. We regularly support clients in preparing for FDA submissions, and we guide them through the regulatory process in alignment with all compliance best practices.

Your Partner in Clinical Research Excellence

When you work with CovarsaDx, you benefit from personalized attention, clinical research expertise, and a team dedicated to accelerating your path to market. We combine strategic insight with operational execution to deliver reliable, timely, and regulatory-ready results. Learn more about our clinical research services, regulatory consulting, and quality assurance offerings.