Studybox Research

Studybox Research IVD-exclusive CRO & site network Carlsbad, California

Real clinics, ready for research.

The IVD CRO that runs your study where your test will be used.

For sponsors For clinics

55+

FDA regulatory clearances

100+

Pre-qualified sites

Studies completed
500+
In IVD research
30 yrs
IVD, no drug trials
100%
Quality system
ISO

In this report

Six sections, one company. Pick a cover.

Our site model

Why waiver studies need real clinics and real operators

A waiver or point-of-care study has to show your test works in the hands of the people who will actually use it. Research sites have the infrastructure but not those people. Clinics have the people but not the infrastructure. Our partner clinics have both.

Traditional research site

  • Research infrastructure: IRB, documentation, compliance
  • Intended use operators: medical assistants, nurses, front-desk staff
  • A real point-of-care setting

Built for research, staffed by research professionals: the wrong operators for a waiver study.

Ordinary clinic

  • Research infrastructure: IRB, documentation, compliance
  • Intended use operators: medical assistants, nurses, front-desk staff
  • A real point-of-care setting

The right operators and patients, but no IRB experience and no appetite for regulatory paperwork.

Studybox partner clinic

  • Research infrastructure: IRB, documentation, compliance
  • Intended use operators: medical assistants, nurses, front-desk staff
  • A real point-of-care setting

An embedded Studybox coordinator carries the protocol, documentation and compliance. The clinic's own staff run your device.

How we run waiver studies

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.

Explore Site Solutions

Representative locations across the network.

CRO and site network under one contract

A CRO brings the regulatory and study expertise. An SMO brings site staff. Studybox is both, so one team owns your study from protocol design to the clinical study report.

Capability CRO SMO Studybox Research
One contract covering the CRO work and the sites
Protocol design and regulatory strategy
Statistics, data management and the clinical study report
Pre-qualified IVD sites with intended-use operators, ready before your study starts
IVD-trained coordinators embedded at each site
Site staffing and day-to-day clinical operations

Case studies

Studies behind real FDA clearances

Real studies from FDA decision summaries. Sponsors stay confidential.

All case studies

  1. No. 01

    Dual 510(k) + CLIA waiver · Infectious disease

    Dual 510(k) and CLIA Waiver Study for a Reader-Based Influenza A/B Antigen Test

    What the study had to show
    Untrained operators, the nurses and medical assistants of urgent care and outpatient clinics, at about 15 CLIA-waived sites.
    Result
    Cleared and CLIA-waived: about 96% influenza A sensitivity in a single season.
    Read the study

  2. No. 02

    Dual 510(k) + CLIA waiver · Hematology

    Dual 510(k) and CLIA Waiver Study for a Point-of-Care Fingerstick PT/INR System

    What the study had to show
    Fingerstick INR run by about 10 untrained operators at 3–5 CLIA-waived sites, for a dual 510(k) and CLIA waiver.
    Result
    Cleared and CLIA-waived, with close agreement to a cleared point-of-care device (slope close to 1).
    Read the study

  3. No. 03

    Dual 510(k) + CLIA waiver · Infectious disease

    Dual 510(k) and CLIA Waiver Study for a Point-of-Care Molecular Strep A Test

    What the study had to show
    A molecular Strep A test run same-day by non-laboratory staff at 8–10 point-of-care sites, judged against culture.
    Result
    Cleared and CLIA-waived: about 96% sensitivity and 97% specificity against culture.
    Read the study

For clinics

Run a clinic? Host IVD studies.

Earn per-patient revenue from single-visit diagnostic studies that fit your daily patient flow. Our embedded coordinators handle the research; no prior research experience is needed.

Explore site solutions

Let's talk IVD research

Wherever you fit in the research process, Studybox is here to support you.

Sponsor or clinic: tell us about your study or your site and we'll follow up within one business day.

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