Services We Offer
Clinical Study for FDA Approval of IVD Products
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Clinical Site Identification
We match your study to sites with the right patient population, investigator experience, and enrollment capacity — reducing delays before your trial even starts.
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Clinical Study Management
From study protocol design and execution to data collection, we manage the day-to-day so your study stays on timeline, on budget, and audit-ready.
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Regulatory-Ready Reporting
We prepare study reports and documentation structured for FDA submission, including 510(k) packages — built to withstand review, not just describe results.
Analytical Testing
Equipped with direct access to CLIA-certified, CAP-accerdited and GLP-compliant high complexity laboratories and experts in laboratory science and technology, we are ready to perform analytical performance evaluations for your product to meet regulatory requirements. We can also help you with research and development to bring your great idea one step closer to the market. Contact us for your specific needs.
Clinical Study Consulting
Study Design & Protocol Development
We translate your device's intended use and regulatory pathway into a clinical study protocol built to generate the data FDA needs — avoiding costly redesigns mid-study.
IRB Application & Submission Support
We prepare and manage IRB applications and ongoing correspondence, keeping your study compliant and moving without administrative delays.
Data Analysis & Interpretation
We analyze study data with the statistical rigor regulatory submission demands — going beyond summary statistics to analysis structured around the questions FDA will ask.
Study Report Preparation
We prepare clinical study reports formatted and substantiated for regulatory review, turning raw results into a clear, defensible narrative.