Decentralized Clinical Trials

Curavit is purpose-built to deliver the future of clinical research to innovative clients in biotech, academic research, and digital therapeutics.

Decentralized Clinical Trials

Digital First Design

To realize the potential of decentralized clinical trials, Curavit teams up with leading research experts in their fields.

Digital First Design

Curavit has a flexible engagement model that scales based on our sponsors’ needs

Curavit’s DCT platform is the digital manifestation of our expertise. It is a HIPAA-compliant, purpose-built stack of validated and industry-proven technology, uniquely configured by our team to execute DCTs in partnership with our clients.

Curavit has a flexible engagement model that scales based on our sponsors’ needs

Curavit delivers trials through Stratus, our proprietary, industry-proven platform

Curavits’ DCT platform is the manifestation of our expertise. It is a HIPAA-compliant, purpose-built stack of validated and industry-proven technology, uniquely configured by our team to execute DCTs in partnership with our clients.

Curavit delivers trials through Stratus, our proprietary, industry-proven platform

Our Services

Curavit delivers a complete suite of CRO services, purpose-built for decentralized clinical trials. From study design and regulatory, through patient enrollment and engagement, to submission, Curavit delivers successful DCTs. Curavits services are designed to be unbundled and tailored to work with your team and your other partners.

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01. Study Design

Curavit works with world-class principal investigators to identify endpoints and create protocols from “first principles” to design studies that are digitally native.

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02. IRB Review

Curavit will manage your Institutional Review Board (IRB) process. We can work with your existing IRB or recommend an IRB for your study.

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03. Diverse Patient Recruitment

Curavit recruits participants from the 97% of potential patients who are traditionally excluded from clinical research. This is done by outlining a streamlined trial execution strategy in alignment with the trial protocol and new FDA diversity requirements. The strategy includes recommendations for optimal patient recruitment methods, technologies, and partners; community/non-profit/patient advocacy partners; preferred sites or combination of alternative sites such as mobile units and home health networks; and, tweaks to protocol designs to optimize participant enrollment across underrepresented groups.

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04. Consent & Enrollment

Curavit screens, consents, enrolls, and engages participants through Stratus, our proprietary DCT platform.

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05. Direct-to-Patient Logistics

Curavit coordinates all of the complex logistics - digital and physical - required to run a fully decentralized trial.

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06. Remote Patient Engagement

Curavit's central site supports 100% remote-based monitoring of patient activity to ensure patient safety, protocol adherence, and retention.

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07. Lab Coordination

Curavit facilitates and manages participants' external labs and integrates the results into Stratus, our proprietary DCT platform.

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08. Clinical Oversight

Curavit's clinical study teams monitor trial data in real time to ensure patient safety, protocol adherence, and patient retention. This incorporates digital consent, telehealth, and remote data capture technologies.

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09. Data Analytics

Curavit's data management team creates the statistical plan and provides full data analysis for the final study report.

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10. Regulatory

Curavit's regulatory affairs team oversees the process of getting your therapy or device through FDA review and approval and onto the market.

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Virtual Central Site

Curavit's Virtual Central Site is where patients, investigators, and Curavit's clinical study team meet to conduct research. Our Virtual Central Site lives in the cloud, is powered by Stratus - our Site platform - and replaces the brick-and-mortar sites used in traditional clinical trials.

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Our Services

Curavit delivers a complete suite of CRO services, purpose-built for decentralized clinical trials. From study design and regulatory, through patient enrollment and engagement, to submission, Curavit delivers successful DCTs. Curavits services are designed to be unbundled and tailored to work with your team and your other partners.

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Upcoming Events

Moving Forward with Decentralized Clinical Trials (DCTs)

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7th - 8th November 2023 - San Francisco Airport Marriott Waterfront, Burlingame, CA

Clinical Outsourcing Group West Coast

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7th - 8th November 2023 - San Francisco Airport Marriott Waterfront, Burlingame, CA

CNS SUMMIT 2023

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2023: November 8-11 - Encore Boston Harbor

Member Organizations

Curavit supports organizations that align with our mission of advancing decentralized clinical trial processes and technologies to speed research and improve patients’ lives.

Curavit in the News

A New Tool for Helping Labs Improve Diversity in Clinical Trials

A New Tool for Helping Labs Improve Diversity in Clinical Trials

November 7, 2023
Rachel Rangel, AuD

Outsourcing Pharma

Improving diversity, equity, and inclusion (DEI) has long been a goal in clinical trials, in order to ensure that research findings apply to the general US population, among other key benefits. Government agencies related to healthcare have made DEI a priority, with the FDA announcing draft guidance for diversity and inclusion in clinical trials in April 2022. The guidance outlines how the makers of drugs and medical devices, including diagnostic tests, can develop a “Race and Ethnicity Diversity Plan” to ensure better representation of historically underrepresented groups in clinical trials of their products. The requirement to include such a plan for most US clinical trials was made law through legislation passed at the end of 2022. However, developing DEI plans will likely present device makers with a variety of challenges. Rachel Rangel, AuD, a clinical trial specialist at Curavit Clinical Research, discusses IDEA, a new toolkit the company launched in June 2023 to help drug and device makers meet federal diversity and inclusion requirements for clinical trials.

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