When you work with NAMSA, you have access to experts who have managed numerous studies in your therapeutic area and geographic location.  

The breadth of knowledge and application experience that our team possesses is enough to power any IVD Program. From infectious disease devices, cardiac markers, diabetes care and point-of-care diagnostics, NAMSA is the IVD CRO leader. We know the market intimately, we understand the sites that can best conduct your IVD trial, and we are familiar with your competition. Most critically, we understand the importance of getting you to market first. Our teams use their expertise to help you navigate your unique regulatory and clinical requirements for the FDA, CE marks, the CFDA and other submissions throughout the world. 

Clinical trial sample collection, processing, and storage can be a logistical difficultly, often overlooked by other CROs. NAMSA’s team will ensure nothing is left off your list. 

NAMSA’s expertise goes beyond specific therapeutic areas. We know what you will face, and make you aware of these challenges while guiding you through the requirements you never even anticipated. This is imperative to product launch success. This expertise has kept us in business for over 50 years, and allows us to serve and keep clients happy every day. Whether you’re working on an IVD FDA submission, an IVD CE mark, or any other global submission, we’re here to support you.

NAMSA’s most requested IVD therapeutic expertise includes:

  • Cardiac Biomarkers
  • Chemistry and Immunoassays
  • Diabetes Management
  • Hematology
  • Histocompatibility & Immunogenetics
  • Infectious Diseases
  • Molecular Diagnostics
  • Oncology
  • Therapeutic Drug Monitoring
  • Women’s/Pre-Natal Care

For a complete list of IVD experience, click here

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