A CRO built for the unique needs of IVD manufacturers.

NAMSA is a leading contract research organization (CRO) that assists In Vitro Diagnostic (IVD) and companion diagnostic manufacturers to translate great ideas into great medical products.

From point-of-care diagnostics to instrument platforms to companion and complimentary devices, NAMSA provides global expertise for the full product development continuum. Through our regulatory, quality systems, and clinical research expertise, we consistently deliver proven time savings and cost efficiencies to clients around the world. This has resulted in hundreds of successful IVD regulatory submissions throughout the U.S., Europe, China, Japan and beyond.

NAMSA understands IVD product development and our specialized IVD team partners with you throughout every step of the process.

At NAMSA, we’ve built our IVD CRO team independent from our medical device team. We utilize only the most specialized IVD experts familiar with the market and who are experienced in guiding sponsors on the correct path to stay ahead of the trends. We work with you to develop the best-fit regulatory strategy that gets you to market faster – before the competition – and supports your future growth objectives. Whatever your goals may be, from laying a solid quality system foundation to post-market launch support, we’ve got you covered.

NAMSA offers product development lifecycle support for regulatory, clinical, and quality initiatives in all IVD therapeutic areas. 

NAMSA’s team of IVD experts are skilled at customizing data collection methods and monitoring plans to appropriately meet site, instrumentation and logistical requirements of each study. Our biostatistics team leverages their unique backgrounds and IVD data expertise to design and analyze IVD trial data to efficiently and cost-effectively launch your unique product.

Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 outside the U.S.) or through our contact form.