StudyboxResearch

IVD Contract Research Organization & Clinical Site Network

IVD-exclusive CRO & site network

55+
Regulatory clearances
100+
Pre-qualified sites

One partner for IVD studies: CRO expertise and curated sites under a single contract.

Who We Are

Studybox Research is a full-service In-Vitro Diagnostic Contract Research Organization and Site Network, offering sponsors expert guidance in IVD studies and exclusive access to our curated IVD sites.

Choose Your Path

Hands transferring a swab sample into an extraction tube beside a rapid test and instructions.

01 For diagnostic manufacturers

I'm a Sponsor

You're running or planning an IVD study and need CRO services, qualified sites, or both.

  • Full-service CRO from protocol to clearance
  • Curated network of pre-qualified IVD sites
  • A single sponsor contract for CRO & Sites
Clinician in a white coat holding a stethoscope, arms crossed.

02 For clinics & points of care

I'm a Clinical Site

You run a clinic, POC, or urgent care and want to host studies that add revenue without disrupting care.

  • Embedded IVD-trained research coordinators
  • Protocols that fit your daily patient flow
  • No prior research experience needed

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

The model

The Strengths of a CRO and an SMO, Under One Roof.

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

Capability CRO SMO Studybox Research
Single sponsor contract for CRO & Sites No No Yes
Master service agreements Yes Yes Yes
Project management from conception to completion Yes No Yes
Regulatory support throughout the project Yes No Yes
Protocol design and development Yes No Yes
Site start-up, monitoring and closeout Yes Yes Yes
eTMF & EDC design & build Yes No Yes
Statistical planning, data management & clinical study report writing Yes No Yes
Study supply management Yes No Yes
Network of pre-qualified, geographically diverse US sites, no study-specific visits needed No No Yes
Curated IVD sites with Intended Use Operators for 510(k), Dual Path 510(k)/CLIA Waiver, and EUAs No No Yes
Embedded IVD trained site Clinical Research Coordinators No Yes Yes
Provide site staff & coordinators No Yes Yes
Manages clinical operations at the site level No Yes Yes

Let's talk IVD research

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

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

I am a…