Clinical Study Strategy & Execution
Generate data to validate in vitro diagnostic performance through clinical study design and execution
End-to-End Support for IVDs
MRIGlobal provides clinical study support for IVDs, including study design, protocol development, and regulatory alignment. Leveraging our CAP-accredited, CLIA-certified laboratories, our team manages sample collection, handling, testing, and logistics while ensuring high-quality data generation in clinically relevant settings. We use an integrated approach with clinical and regulatory working hand-in-hand to help demonstrate clinical utility, reduce regulatory risk, and accelerate clearance and market readiness.
Clinical Studies for In Vitro Diagnostic Validation
Protocol and Statistics Planning
Develop protocols that define study objectives, endpoints, and statistical approaches to validate diagnostic performance.
Clinical Study Evaluation and Reporting
Collect, curate, and analyze clinical data, and author clinical study reports for regulatory submission.
Latest from the blog
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Point-of-Need Diagnostics
Have you ever swabbed inside your nose and used that sample to help diagnose if you have the flu or COVID-19? Or maybe you peed on a pregnancy test. The technology that makes those and other diagnostic tests like them possible is rooted in chemistry and enables people to manage their health from the privacy […]
Assay & Method Development Biological Threats Clinical Study Strategy & Execution -
Six Stages to Developing a Novel Infectious Disease Assay
Respiratory illnesses are generally characterized by a fever, a cough, and a sore throat. These kinds of infections are common during fall and winter and can occur in either the upper or lower respiratory tract. As the winter season gives way to spring, you may be reflecting on your own recent bouts of illness. Within, […]
Assay & Method Development Biological Threats Clinical Study Strategy & Execution -
Navigating Regulatory Challenges in Assay Development
Clear regulatory planning and early FDA engagement are critical to navigating IVD development and avoiding costly delays. Our expertise helps organizations establish the right documentation, refine study designs, and adapt to evolving FDA expectations throughout the development process.
Assay & Method Development Clinical Study Strategy & Execution Pathogen Assay Development
