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D-COHRe

Decentralized Clinical Operations for
Healthcare and Research

Forming novel partnerships with healthcare and clinical research organizations to advance decentralized clinical trials and research studies

The COVID-19 pandemic highlighted several gaps in the traditional clinical trial infrastructure for clinical evaluation of medical countermeasures (MCMs) during a public health emergency (PHE).

  • Lack of access to decentralized infrastructure hindered the ability of MCM developers to run successful trials for product validation in real-world environments.
  • Limited mechanisms to engage potential participants for clinical trials in remote settings, such as the home, where many of these products are intended to be used.
  • Difficulty accessing diverse and representative populations for participation in clinical trials.

MISSION

Build a sustainable business model for decentralized clinical trials (DCTs), providing a means for rapid clinical validation and implementation of novel technologies and approaches for PHE preparedness that would not be feasible through the traditional clinical trial infrastructure. 

OBJECTIVES

D-COHRe aims to lead the paradigm change for BARDA in preparing for PHEs.

Identify and address challenges in successfully implementing DCTs

Catalyze and create lasting sustainable business models for DCTs beyond BARDA support

Create capability for evaluating BARDA products in real-world environment

Partner Acitivies

Capability Build: Expand and enhance decentralized services and capabilities to foster growth and sustainability of DCTs.

Data Analytics: Gather and analyze qualitative and quantitative data to inform on the value and impact of DCTs.

Clinical Studies: Conduct clinical studies in real world environments:

Product Development:
Validate MCMs to support regulatory submission

Product Adoption and Utilization:
Demonstrate value of MCMs and clinical management approaches

Clinical Trial Innovation:
Pilot/validate novel approaches and enablers to enhance DCTs for future MCM development

THE FUTURE OF CLINICAL TRIALS

Novel partnerships with decentralized healthcare and clinical research capabilities will revolutionize the landscape of clinical research. This unprecedented approach enables BARDA and MCM developers to conduct clinical trials with enhanced efficiency and relevance while increasing access and participation among diverse patient populations.

These advancements will facilitate more robust and representative clinical research by enabling comprehensive and regular collection, including patient-generated and patient-reported data. Data collection can occur over longer time frames and in real-world settings, providing a holistic understanding of disease etiology, progression, and outcomes.

This evolution in clinical trials will bring a future where clinical trials are more accessible and inclusive, resulting in novel and effective MCMs.

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Increase access and participation of more diverse patient populations to enable robust and representative clinical research

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Allow for rapid and flexible clinical validation of novel technologies and approaches for pandemic preparedness

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Facilitate more comprehensive and regular data collection including patient-generated and patient-reported data

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Collect data over longer timeframes and in real-world settings offering a fuller understanding of disease etiology, progression, and outcomes

BE PART OF THE FUTURE

For organizations with decentralized clinical research capabilities:

Explore D-COHRe partnering opportunities to join our team of partners revolutionizing clinical research.

For MCM developers interested in decentralized clinical research:

Contact us to discover how D-COHRe can support your clinical trials.

BARDA and MCM developers can use D-COHRe to conduct clinical studies

NEWS & PUBLICATIONS

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DRIVe’s D-COHRe Program Announces First Partners to Improve Sustainability of Decentralized Clinical Trials

These partnerships will support innovative DCT capabilities that will have lasting impact for clinical research, building our public health emergency preparedness.

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Care Access Enters into Strategic Partnership with U.S. Department of Health and Human Services to Enhance Nation’s Pandemic Preparedness

Care Access and BARDA seek to utilize Care Access’s decentralized clinical trial network to increase vaccine and treatment access for underserved and hard-to-reach communities.

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Walgreens and BARDA Form Strategic Partnership to Strengthen Decentralized Clinical Trials Model and Reporting

This first-of-its-kind collaboration between Walgreens and U.S. government aims to address barriers in decentralized clinical trial access and conduct trials over a five-year period, valued up to $100...

Program Goals
Allucent Receives BARDA-Funded Project NextGen Award to Support a COVID-19 Vaccine Decentralized Clinical Trial

Allucent, a global mid-sized clinical research organization (CRO), announced today that it has been selected by the Biomedical Advanced Research and Development Authority (BARDA) . . .

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BARDA updates the D-COHRe program, seeking to enhance clinical innovation with decentralized care capabilities

BARDA's Division of Research, Innovation, and Ventures (DRIVe) has updated the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership solicitation. . .