Studybox Research

Studybox Research Site network services

CLIA waiver and point-of-care study sites

Use our 100+ pre-qualified U.S. partner sites on their own or as part of a full CRO engagement. Urgent care, point-of-care and home-use settings, with intended-use operators, including untrained operators, already in place.

Plan your site mix

The network

Site network services

Our site model

The operator problem in waiver studies

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.

Why it's faster

Sites ready before your protocol is

Need the whole study run? Pair the sites with our IVD clinical research services.

  1. 01

    Intended-use operators

    Sites staffed for 510(k), dual 510(k)/CLIA waiver and EUA studies, including untrained operators in genuine waived settings.

  2. 02

    No qualification visits

    Sites are pre-qualified for IVD protocols, so there are no study-specific qualification visits before enrollment.

  3. 03

    Activation in about four weeks

    Typical activation is about four weeks from study initiation, versus a three-to-six-month industry average.

  4. 04

    Embedded coordinators

    IVD-trained Studybox coordinators work on site, across point-of-care, urgent care and home-use settings.

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.

Talk sites with our team

Representative locations across the network.

Scope

What we handle and what you keep

Studybox handles

  • 01Pre-qualified sites with intended-use operators
  • 02Site start-up, monitoring and closeout
  • 03Embedded IVD-trained coordinators

You keep

Your protocol, CRO and regulatory strategy.

Sponsor retains

Case studies

Studies run in this network

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

Let's talk IVD research

Plan your site mix

Tell us the intended use, the operator profile and the settings you need. We'll follow up within one business day.

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