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IVD & Companion Diagnostics Clinical Research Organization


IVD Trial Sites Managed


IVD Clinical Trials


IVD Regulatory Submissions


Monthly IVDR Tech File & Gap Assessments

NAMSA’s stand-alone IVD business unitthe only one within the Contract Research Organization (CRO) industryis focused on meeting the unique product development needs of IVD manufacturers. We help clients fast-track the commercialization of life-changing IVD products through our proactive research approach and in-depth knowledge of IVD requirements.

Our experts partner with your team to meet their needs on a global scale, whatever they may be. Some clients choose to outsource all regulatory, quality, reimbursement and clinical IVD research initiatives, while others collaborate with us on portions of their regulatory or clinical study processes. No matter your needs, NAMSA is the most flexible diagnostics clinical research organization in the industry and we pride ourselves on delivering high-quality results by leveraging our collective global expertise. 

Some of our most frequently requested IVD therapeutic areas include:

  • Clinical Chemistry
  • Companion Diagnostics
  • Direct to Consumer Testing (DTC)
  • Drugs of Abuse Testing
  • Hematology
  • Hemostasis/Coagulation
  • Histology and Cytology
  • Immunochemistry
  • Microbiology Culture
  • Molecular Diagnostics
  • Point of Care Testing

NAMSA is a diagnostics clinical research organization with a dedicated IVD research team that takes the guesswork out of IVD product commercialization, development and regulatory compliance. Learn more about how we can help meet your unique needs.

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NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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Do’s & Don’ts for Early-Stage IVD Product Development & Risk Mitigation
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