About Studybox

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.

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.

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.

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.

We focus on reproducibility, specimen collection, near cut-off, and intended-use studies for IVDs, ensuring reliable results that meet FDA expectations.