Redefining Clinical Studies

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.

Work With Us

Design

Protocol Development · Regulatory Strategy · Study Planning

01

Execute

Site Operations · Enrollment · Supply Managment

02

Monitor

Real-time dashboards · Data Analylis · QA
· Oversight

03

Submit

Study reporting · FDA support · Clearance readiness

04

Our Services

Integrated CRO services supporting IVD studies from planning through submission.

Clinical Study Design

Site Operations & Management

Regulatory Strategy

Quality & Compliance

Study Planning & Protocols

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.

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.