Studybox Research For sponsors
IVD study services for sponsors
An IVD-only CRO for 510(k), CLIA waiver and EUA studies, from a team with 55+ FDA clearances. Hand us the whole study, just the sites, or just the specimens.
Report to sponsors
For sponsors
How sponsors work with us
As much or as little as you need
Hand us the whole study, or just the part that's hardest to staff. Either way, one contract.
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Full-service CRO
We run the whole study, from protocol to clearance.
Studybox handles
- Protocol design and regulatory strategy
- Sites, IRB and coordinators
- Monitoring, data and statistics
- Clinical study report
You keep
Your device and the final submission decisions.
Details -
Site network services
Our sites and coordinators, inside your study.
Studybox handles
- Pre-qualified sites with intended use operators
- Site start-up, monitoring and closeout
- Embedded IVD-trained coordinators
You keep
Your protocol, CRO and regulatory strategy.
Details -
Specimen collection
Fresh specimens, without starting a study.
Studybox handles
- Collection under our pre-approved IRB protocol
- Common specimen types, more on request
- Custom data capture with each specimen
You keep
Your testing and analysis.
Details
Our process
How a study runs, protocol to clearance
One team, one point of contact, zero handoffs. Meet the team.
- 01
Protocol design
We design or refine your protocol to meet FDA requirements and maximize site feasibility.
- 02
Regulatory strategy
We map the right regulatory pathway: 510(k), CLIA Waiver, Dual Submission, Emergency Use Authorization, De Novo, Reproducibility and Precision studies.
- 03
Site selection
We match your IUO profile to sites across our established network for rapid activation.
- 04
Study execution
Enrollment, supply management, and site operations run under our direct oversight.
- 05
Real-time monitoring
Live dashboards, data review, QA, and deviation management throughout the study.
- 06
Submission ready
Study report, FDA response support, and clearance readiness delivered on time.
FAQ
Sponsor questions
Answers to what sponsors ask us first. Anything else, ask us directly.
01 How quickly can you activate a study?
Because our sites are pre-qualified for IVD protocols, we can typically activate within approximately 4 weeks of study initiation, compared to the 3 to 6 month industry average.
02 What study types do you support?
We support 510(k), CLIA Waiver, Dual Submission, Emergency Use Authorization, De Novo, reproducibility and precision studies.
03 How do you handle protocol amendments?
Our regulatory team reviews protocols before study start to minimize amendment risk. When amendments do occur, we manage the IRB/Ethic's Committee communication and site updates end-to-end.
04 Do you work with companies outside the US?
Yes. We work with international sponsors seeking FDA clearance for their IVD products, providing US-based site networks and regulatory expertise.
05 What is your typical study timeline?
Timeline depends on study complexity, enrollment requirements, and regulatory pathway. We provide detailed project timelines at study initiation and update them weekly throughout execution.
Start the conversation
Tell us about your program
Tell us about your program and we will follow up within one business day.
Prefer to email?
info@studyboxresearch.comSponsor inquiryForm S-1