Diagnostic Studies
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Advancing IVD Clinical Studies with a Full Service CRO and IVD Site Network

Studybox Research is a full-service In-Vitro Diagnostic (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.

A new integrated approach...

CRO
SMO
Studybox
Research
Single Sponsor contract for CRO & Sites
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Master service agreements
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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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Provide site staff & coordinators
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Manages clinical operations at the site level
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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 monitors analyze your data daily to identify 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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Lets Talk IVD Research!

Contact us to learn more about our services.

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