Diagnostic Expertise
Full-service execution from protocol design through regulatory submission.
For sponsors
Sponsor Solutions
Studybox partners with IVD sponsors as a strategic advisor and hands-on executor. We bring the diagnostic expertise, the right sites, and the operational infrastructure so your study moves faster, costs less, and gets done right.
50+
Regulatory clearances
30+
Years of experience
100%
IVD exclusive focus
100+
Pre-Qualified Sites
Clinical research services
We Don't Do Drugs.
Every study we run is an in vitro diagnostic study: from protocol to FDA response, one team, one point of contact, zero handoffs.
Accelerated Timelines
Pre-established site relationships matched to your IUO profile.
Extensive Network
Site network spanning demographics, geographies, and clinical settings.
Simplified Complexities
Streamlined pathways under a single point of expertise.
Our process
From Protocol to Clearance.
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Protocol Design
We design or refine your protocol to meet FDA requirements and maximize site feasibility.
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Regulatory Strategy
We map the right regulatory pathway: 510(k), CLIA Waiver, Dual Submission, Emergency Use Authorization, De Novo, Reproducibility and Precision studies.
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Site Selection
We match your IUO profile to sites across our established network for rapid activation.
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Study Execution
Enrollment, supply management, and site operations run under our direct oversight.
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Real-Time Monitoring
Live dashboards, data review, QA, and deviation management throughout the study.
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Submission Ready
Study report, FDA response support, and clearance readiness delivered on time.
Site Network
100+ Pre-Qualified Sites Across the U.S.
A geographically diverse clinical research site network spanning point-of-care, urgent care, and home-use settings, pre-qualified, saving you time and money.
Specimen collection
Prospective Specimen Collection.
Launch new collections in as little as one week, with no study startup required.
Studybox maintains a pre-approved IRB protocol covering the most common specimen types, so sponsors can access fresh, prospectively collected specimens without the time or cost of initiating a dedicated study. Data capture is fully customizable to your needs, including demographics, concomitant medications, symptom onset, symptom profile, and more.
FAQ
Everything You Need to Know.
01 How quickly can you activate a study?
Because our sites are pre-qualified for IVD protocols, we can typically activate within approximately 4 weeks of study initiation, compared to the 3 to 6 month industry average.
02 What study types do you support?
We support 510(k), CLIA Waiver, Dual Submission, Emergency Use Authorization, De Novo, reproducibility and precision studies.
03 How do you handle protocol amendments?
Our regulatory team reviews protocols before study start to minimize amendment risk. When amendments do occur, we manage the IRB/Ethic's Committee communication and site updates end-to-end.
04 Do you work with companies outside the US?
Yes. We work with international sponsors seeking FDA clearance for their IVD products, providing US-based site networks and regulatory expertise.
05 What is your typical study timeline?
Timeline depends on study complexity, enrollment requirements, and regulatory pathway. We provide detailed project timelines at study initiation and update them weekly throughout execution.
Start the conversation
Tell Us About Your Program.
Tell us about your program and we will follow up within one business day.
Prefer to email?
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