Diagnostic studies
done right

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.

Site Network

CRO Services

A new integrated approach...

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

We simplify the process by seamlessly integrating all essential components to accelerate your studies with precision and efficiency.

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CRO

SMO

Studybox
Research

Single Sponsor contract for CRO & Sites

Master service agreements

Project management from conception to completion

Regulatory support throughout the project

Protocol design and development

Site Start-up, monitoring and closeout

eTMF & EDC design & build

Statistical planning, data management & clinical study report writing

Study supply management

Network of pre-qualified, geographically diverse US sites—no study-specific visits needed.

Curated IVD sites with Intended Use Operators for 510(k), Dual Path 510(k)/CLIA Waiver, and EUAs.

Embedded IVD trained site Clinical Research Coordinators

Provide site staff & coordinators

Manages clinical operations at the site level

At Studybox, we give sponsors and CROs the site-level insights and tools they need, making every stage of clinical research more efficient and reliable.

Expertise Meets Innovation

Expert CRO and Site Network Services

Studybox Research CRO

Focused exclusively on IVDs, we provide expert monitoring from start to finish. With 50+ regulatory clearances, our team specializes in 510(k), CLIA Waivers, EUA, and reproducibility studies. We deliver regulatory support, streamlined submissions, and efficient pathways from study design through approval.

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Studybox Research Sites

Our network spans diverse clinical environments POC, urgent care, and home-use ensuring studies reflect real-world IVD use. Sites access representative patient populations and support waived, moderate, and high complexity testing. With daily patient flow, protocols integrate seamlessly into clinic operations under the guidance of Studybox research coordinators.

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Studybox combines the strengths of a CRO and SMO, giving sponsors a single partner for regulatory expertise and real-world clinical execution.

Lets Talk IVD Research!

Sponsor, CRO, or clinic—wherever you fit in the research process, Studybox is here to support you. Fill out the form and our team will connect with you directly to discuss your study needs, answer your questions, and help you move forward with confidence.

Support

Frequently Asked
Questions

What makes Studybox different from other CROs or SMOs?

Studybox focuses exclusively on in-vitro diagnostics (IVDs). Unlike traditional CROs or SMOs, we combine CRO expertise with a dedicated network of IVD sites, streamlining studies and accelerating regulatory approval.

What is the process for Starting a study with Studybox?

Simply reach out to our team with your study goals. We’ll guide you through site selection, protocol design, regulatory strategy, and study launch ensuring a seamless experience from start to finish.

Do Studybox sites reflect real-world clinical environments?

Yes. Our geographically diverse network includes Point of Care (POC), urgent care, and home-use settings, ensuring your study captures data that reflects real-world IVD use.

Can Studybox support regulatory submissions?

Absolutely. With IVD operations and regulatory expertise, we simplify and accelerate your clinical research. Our team supports study planning, electronic study management, data analysis, regulatory submission, and agency communication, all backed by an ISO 9001:2015 and 20916:2019 compliant quality system.

What type of studies does Studybox specialize in?

We focus on reproducibility, specimen collection, near cut-off, and intended-use studies for IVDs, ensuring reliable results that meet FDA expectations.

Diagnostic studiesdone right