Clinical & Regulatory

Clinical Research Services

Our team integrates seamlessly with your Design & Development project in preparing and executing comprehensive evidence-based clinical & regulatory plans. These studies support Validation & Clinical Trials for every type of IVD product.
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Complete Verification, Validation & Clinical Study Solutions

Our Capabilities

Complete Validation Packages
Design & Development Plans
Flex Study Protocol writing & execution
Complete Clinical Trial Management
Data management & biostatistics
Transfer to Manufacturing, in-house or to client site
Facility & Vendor Audits
Verification Study Packages

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Whether you're starting with a concept or are an established diagnostics company, we offer expertise in rapid testing, manufacturing, and comprehensive services to meet your needs efficiently and effectively.
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