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Diagnostic Studies
Done Right.

Advancing IVD clinical studies
with a full service CRO and IVD site network

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About us

Studybox Research is a full-service IVD Clinical Research Organization and Site Network, offering sponsors expert guidance in IVD studies and exclusive access to our curated IVD sites.
We simplify the process by seamlessly integrating all essential components to accelerate your studies with precision and efficiency.

Studybox Research CRO

We don’t do drugs! Our focus is 100% on IVDs. Diagnostic studies are different and need to be carefully monitored from start to finish. Our internal data team analyzes your data daily for trends and anomalies.
We are IVD experts in 510(k), Dual Path 510(k)/CLIA Waiver, OTC, EUA, Specimen collection, Reproducibility, and Near Cut Off studies. Our team has 50+ regulatory clearances.
Regulatory support for device classification, submission pathway options, predicate device research, 510(k), Dual Path 510(k)/CLIA Waiver and EUA submissions.
Streamlined process from study start up to regulatory submission.
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Studybox Research Sites

Geographically diverse sites that reflect the actual environments of IVD use, including Near Patient/ Point of Care (POC), Urgent Care, and Home-Use settings. 
Target populations that are representative of intended patient population(s).
Sites can support the necessary intended use operators for waived, moderate, and high complexity testing based on your study needs.
Sites see patients daily, seamlessly integrating study protocols into clinic operations, allowing staff to efficiently handle patient care, testing, and study tasks with the assistance of the Studybox research coordinator.
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A new integrated approach...

CRO
SMO
Studybox
Research
Single Sponsor contract for CRO & Sites
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Master service agreements with IRBs and Reference Labs
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Project management from conception to completion
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Regulatory support throughout the project
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Protocol design and development
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Site Start-up, monitoring and closeout
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eTMF & EDC design & build
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Statistical planning, data management & clinical study report writing
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Study supply management
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Network of pre-qualified, geographically diverse US sites—no study-specific visits needed.
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Curated IVD sites with Intended Use Operators for 510(k), Dual Path 510(k)/CLIA Waiver, and EUAs.
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Embedded IVD trained site Clinical Research Coordinators
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Mobile medical unit for decentralized studies or testing events
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Get Started with Studybox

Ready to make a difference through IVD research?

Contact us to learn more about our community-focused studies and how you can contribute to pioneering healthcare improvements.

Accelerating IVD Clinical Studies Through Expertise and Accessibility Icon

Accelerating IVD Clinical Studies Through Expertise and Accessibility:

Specialized Site Cultivation: Leveraging our expertise in IVD clinical studies, we cultivate sites specifically tailored to efficiently conduct IVD research.

Access to Diverse Populations: We reach underserved and diverse populations to ensure studies meet regulatory guidelines and provide comprehensive data.

Usability Evaluation: Quickly identifying potential use errors in the study specific to targeted populations for optimized study outcomes.

Streamlined Contracts & Site Network: An expedited contract process with an extensive geographical site network enables faster study start-ups and broadens site access.

From Research to Results Icon

From Research to Results

With deep expertise in IVD studies, we bring a thorough understanding of FDA guidance, offering the knowledge and confidence essential for successful, compliant research partnerships.

Studybox Research logo representing clinical research expertise and support for underserved communities.