CovarsaDx

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Your trusted CRO partner for IVD and medical device studies

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Specialized in IVD & Medical Device Clinical Trials: From Study Design to Regulatory Approval

Our Services

Clinical Research

Comprehensive IVD & Medical Device Clinical Trial Management

Regulatory Consulting

Expert Guidance on FDA Submissions: 510(k), De Novo, PMA

Quality Assurance

Ensuring Compliance with Global Regulatory Standards in Clinical Trials

Partner with Us

Accelerate Market Access for Your IVD or Medical Device

At CovarsaDx, we specialize in IVD and medical device clinical trials designed to meet FDA requirements and speed time to market. With deep expertise in regulatory consulting and clinical study design, we help sponsors navigate complex De Novo, 510(k), and EUA pathways with confidence.

We collaborate closely with sponsors and clinicians to design studies grounded in disease pathophysiology, patient population data, and clinical impact—ensuring your trial is scientifically sound, regulatory-ready, and built for success.

Meet our Leadership Team

Our leadership team brings deep expertise in IVD and medical device clinical research, regulatory consulting, and quality assurance. With decades of combined experience guiding FDA submissions and global trials, CovarsaDx’s leaders are committed to accelerating innovation through customized study strategies and regulatory clarity.

Chermaen Lindberg

President & CEO

David Ikeda

Sr. Director, Clinical Operations and Regulatory Strategist

Dennis Broyles

Sr. Director, Data Management and Clinical Strategist

Marielle Lejcher

Sr. Director of Regulatory Affairs and Quality Assurance

Rich Masino

Sr. Director of Strategic Partnerships and Business Development

By far the best CRO I've worked with, from the company owner to every employee, everyone is highly capable, knowledgeable, and experienced across all areas from regulatory to quality to clinical. Most importantly, they genuinely care about their clients, consistently prioritizing our needs even when it means less profit for them. Their client-first approach is truly commendable.
Frank LuoDirector, Azure Biotech Inc.
CovarsaDx’s personalized and responsive support were critical to our success. Their team was deeply engaged at every stage, ensuring world-class execution of our DASH® SARS-CoV-2 & Flu A/B Test clinical study.
Alan BlakeCEO, Nuclein
CovarsaDx is highly professional and very efficient in communication. It is also friendly to work with and is always client oriented.
Bingliang FangCEO, Healgen Scientific
CovarsaDx has been an exceptional partner to OSANG LLC since we began working together during the pandemic. Their commitment to customer success truly shines through in every interaction. The CovarsaDx team is not only knowledgeable but also incredibly supportive and responsive, consistently putting our goals first. Their proactive approach and genuine care for our progress have made a significant impact on our clinical research efforts. I highly recommend CovarsaDx to any organization looking for a CRO that truly goes above and beyond for its clients.
Dan LeeCEO, OSANG LLC
Working with the CovarsaDx team has been an absolute pleasure. Their expertise and dedication shone through every step of the clinical research process. Thanks to their support and guidance, we felt confident tackling complex regulatory requirements and were able to achieve fantastic results together.
Jonathan MaaCEO, Maxim Biomedical, Inc.

Partner with Experts in IVD and Medical Device Research

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