Diagnostic Studies Done Right

Advancing IVD clinical studies with knowledge and inclusion

Join Us

Who We Are

Mission

Leveraging our IVD expertise to accelerate client studies, expand site access, and empower underserved communities.
At Studybox, our IVD expertise accelerates clinical studies, expands diverse site access, and empowers underserved communities. With strategic site representation and seamless support, we drive each study with precision, efficiency, and impact.

Site Representation

Studybox partners with geographically diverse sites that reflect the actual environments for IVD use, including Point of Care (POC), Physician Office Lab (POL), Urgent Care, and Over-the-Counter (OTC) settings.

Intended Patient Population

Our sites have the target populations that are representative of the intended patient population(s).

Intended Use Operators

Depending on your study needs, our network of sites can accommodate the required intended use operators for waived, moderate, and high complexity testing.

Integrated Study Testing

Our sites are seeing patients on a daily basis. Your study protocols are integrated into the clinics daily operations, allowing multitasking clinic staff to seamlessly conduct patient care, testing, and study-specific duties.

Advancing IVD Clinical Studies

Join us in accelerating the future of IVD clinical research by expanding access to underserved communities. With unparalleled expertise in IVD studies, we deliver precision, compliance, and impactful results—making us the trusted partner for sponsors seeking excellence in diagnostic research.

How Studybox Works

Seamless Integration

We embed IVD-trained study coordinators in clinics to oversee study processes—from patient recruitment and data compliance to coordinating on-site testing, while utilizing clinic staff for specimen collection and testing.

Fostering the Gap

Our dedicated study coordinators manage all logistical elements,
from study initiation to completion, ensuring clinics have the support they need.

Education to Providers

Studybox equips healthcare providers with comprehensive clinical study training, enhancing awareness and patient participation across their network.

Get Started with Studybox

Ready to make a difference through IVD research?

Contact us to learn more about our community-focused studies and how you can contribute to pioneering healthcare improvements.

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Accelerating IVD Clinical Studies Through Expertise and Accessibility:

Specialized Site Cultivation: Leveraging our expertise in IVD clinical studies, we cultivate sites specifically tailored to efficiently conduct IVD research.

Access to Diverse Populations
: We reach underserved and diverse populations to ensure studies meet regulatory guidelines and provide comprehensive data.

Usability Evaluation
: Quickly identifying potential use errors in the study specific to targeted populations for optimized study outcomes.

Streamlined Contracts & Site Network
: An expedited contract process with an extensive geographical site network enables faster study start-ups and broadens site access.

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IVD Experts in

510(k), CLIA Waiver, Dual Submissions, OTC, EUA, Specimen collection, Reproducibility, and Near Cut Off studies.

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From Research to Results

With deep expertise in IVD studies, we bring a thorough understanding of FDA guidance, offering the knowledge and confidence essential for successful, compliant research partnerships.

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Mobile Research: A Site On Wheels

Take your research to the patients in our mobile medical unit.

Studybox is proud to offer a mobile clinic dedicated to Decentralized Trials for IVD studies, exclusively serving the Southern California area with more areas to come.

Designed to expand opportunities for participation among underrepresented populations, our mobile clinic brings IVD research closer to patients, enhancing accessibility and convenience.

Each visit is meticulously managed to meet the standards of traditional research sites, ensuring exceptional data quality and a seamless patient experience. With Studybox’s mobile clinic, sponsors and CROs can confidently reach and engage diverse communities, advancing IVD research in a more inclusive and impactful way.

IVD Focus

Icon representing Coagulation testing

Coagulation

Icon representing Infectious Disease testing

Infectious Disease

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Drugs of Abuse

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Women’s Health

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Gastro

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STD/STI

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Colorectal

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Hematology