We streamline and expedite the IVD clinical research process, leveraging our regulatory expertise and curated site network to help bring your IVD test to market faster and more efficiently.
End-to-end support from start-up to closeout, including protocol design and execution.
Real-Time Oversight
Centralized systems for eConsent, eSource, eTMF, EDC, and project planning with live dashboards.
Curated IVD Site Network
Specialized sites with embedded coordinators to ensure smooth study operations.
Data & Reporting
Comprehensive data analysis, clinical study report writing, and regulatory-ready outputs.
Regulatory Expertise
Submission strategy, agency communication, and comparator testing via IVD reference labs.
Quality Management
ISO 9001:2015 certified processes for compliance and consistency.
Contact Us
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.
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