Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Partnership Solicitation
ID: 2023-BARDA-DCOHReType: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFOFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSEBARDA - ASPR / DAAPPO / BARDA DCMAWASHINGTON, DC, 20515, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; EXPERIMENTAL DEVELOPMENT (AN13)

Original Source

https://sam.gov/opp/efdf093148894b2dbbcd10d6fc0e1acb/view
Timeline
    Description

    Solicitation HEALTH AND HUMAN SERVICES, DEPARTMENT OF is seeking partnerships with organizations providing decentralized healthcare services or Clinical Research Organizations (CROs) with decentralized capabilities. The Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program aims to establish a strong decentralized clinical research capability to support medical countermeasure development and utility.

    Point(s) of Contact
    Matthew McCord, OTAO
    LaunchOfficeContracting@hhs.gov
    Christopher Muntz, OTAS
    LaunchOfficeContracting@hhs.gov
    Files
    Title
    Posted
    Amendment 001 - D-COHRe.pdf
    AMENDMENT 001 ISSUANCE updates the file name and removes sensitive information from the header, while also changing the proposal due date and adding information about early submissions and potential award evaluation.
    Amendment 001 - D-COHRe.pdf
    Amendment 001 for the Strategic Partnership Solicitation for Decentralized Clinical Operations (D-COHRe) on June 28, 2023, updates the solicitation file name and removes sensitive designation from the header. It changes the submission deadline from June 19, 2024, to June 1, 2024, and elaborates on proposal evaluation timelines, encouraging early submissions. Proposals received by July 25, 2023, may be considered for awards by September 30, 2023.
    Amendment 002 - D-COHRe.pdf
    Amendment 002 for the Strategic Partnership Solicitation (D-COHRe BI BARDA N) issued on July 12, 2023, provides answers to questions submitted regarding the solicitation and includes updated official email addresses for inquiries. Respondents are directed to email hi3@hhs.gov for market research requests and LaunchOfficeContracting@hhs.gov for other questions. The amendment also adds a link to the relevant website: https://drive.hhs.gov/dcohre.html.
    Amendment 002 - D-COHRe.pdf
    This amendment provides answers to questions submitted to BARDA for the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) solicitation and updates the official email addresses for inquiries. It also includes a website link for further information.
    Amendment 003 - D-COHRe.pdf
    Amendment 003 for the Strategic Partnership Solicitation for Decentralized Clinical Operations for Healthcare and Research (D-COHRe) was issued on July 21, 2023. The amendment's purpose is to post responses to questions submitted to BARDA regarding the solicitation, available in the attached document.
    Amendment 003 - D-COHRe.pdf
    Amendment 003 has been issued for the Strategic Partnership Solicitation for Decentralized Clinical Operations for Healthcare and Research (D-COHRe) by BARDA N. This amendment includes the posting of answers to various questions that were submitted to BARDA for the solicitation.
    Amendment 004 - D-COHRe.pdf
    Amendment 004 for the Strategic Partnership Solicitation for Decentralized Clinical Operations has paused the solicitation for proposals until further notice, with new submissions during this time not being evaluated. The submission deadline has been extended to October 31, 2024, and updates regarding the solicitation will be posted on SAM.gov. The amendment clarifies that proposals will only be accepted after the solicitation is un-paused, and encourages early submissions due to potential funding limitations.
    Amendment 005 - D-COHRe.pdf
    Amendment 005 reopens the solicitation for proposals related to Decentralized Clinical Operations for Healthcare and Research (D-COHRe) and extends the submission deadline to December 9, 2024. It also updates program goals, proposal requirements, and evaluation criteria, and introduces a new RFP Statement of Work Template to assist respondents. Proposals may be considered for potential awards in fiscal year 2025.
    Attachment 1 - D-COHRe RFP Business Proposal Template.xlsx
    The document outlines the cost estimation process for a proposal related to an initial capability build and clinical study pricing for BARDA funding, with a maximum of $2 million. It includes a requirement for detailed breakdowns of costs, including direct labor, indirect rates, travel, and subcontracting, along with supporting documentation for proposed rates. Additionally, it emphasizes the need for justification of the labor rates and their alignment with market standards for future clinical studies.
    Attachment 1 - D-COHRe RFP Business Proposal Template.xlsx
    The document outlines the pricing proposal for the initial capability build, necessitating a detailed breakdown of costs by category, including labor, materials, travel, and subcontractor expenses, with the total proposed value capped at $2 million for BARDA funding. Additionally, it states the requirement of supporting documentation for the clinical study pricing to justify personnel and indirect labor rates for budget projections. The focus is on ensuring the proposed costs are documented correctly and align with the solicitation instructions before submission.
    Attachment 2 - D-COHRe RFP SOW Template.docx
    The Statement of Work (SOW) outlines a partnership between BARDA and [Partner] aimed at enhancing decentralized clinical research capabilities over a five-year period. Key activities will include program management, conducting decentralized clinical trials, and continuous reporting on qualitative and quantitative metrics. The agreement allows for additional activities to be added upon mutual agreement and focuses on developing a sustainable model for decentralized clinical operations and research.
    BARDA D-COHRe Questions and Answers_12Jul23.pdf
    BARDA's decentralized clinical operations partnership is open to companies located outside of the U.S., with the exclusion of certain non-responsive respondents focused solely on advancing their own products or technologies. BARDA's goal is to develop decentralized clinical study capabilities through the partnership, and they will collaborate with the partner to conduct the clinical study. Respondents can use the funding to incorporate or develop specific technologies to enhance decentralized clinical study readiness.
    BARDA D-COHRe Questions and Answers_12Jul23.pdf
    The document summarizes questions and answers regarding a funding solicitation from BARDA, indicating that companies outside the U.S. may apply if they meet specified criteria. It clarifies that while BARDA expects partners to develop decentralized clinical study capabilities, they should be well-prepared to conduct studies domestically. Additionally, respondents can include pricing models with annual escalation factors in their proposals for the 5-year base period, which encompasses capability building.
    BARDA D-COHRe Questions and Answers_21Jul23.pdf
    The document outlines a series of questions and answers regarding the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Strategic Partnership solicitation, including details on proposal submissions, eligibility criteria, commitment terms, regulatory oversight, and the evaluation process. BARDA encourages organizations to submit only one proposal and emphasizes a five-year commitment for awarded partnerships, while also clarifying that proposals submitted after the deadline will be considered on a rolling basis without a specific timeline for future award dates. Additionally, potential respondents are advised to review the solicitation thoroughly to ensure alignment with eligibility requirements and capabilities before applying.
    BARDA D-COHRe Questions and Answers_21Jul23.pdf
    BARDA prefers that respondents submit only one proposal for the D-COHRe strategic partnership solicitation, but there is no explicit prohibition against multiple proposals. The OT agreement awarded to the respondent commits them to a minimum five-year relationship with BARDA. There is no definitive timeline for the next scheduled award date, but successful proposals will be executed as soon as funding becomes available in the next fiscal year. All interested parties who meet the eligibility requirements can apply for the solicitation. The D-COHRe solicitation is not intended for companies developing their own technologies; it is focused on partners with current or planned capabilities to conduct decentralized clinical research. Proposal submissions for D-COHRe should be sent to LaunchOfficeContracting@hhs.gov. The regulatory oversight for projects funded through the solicitation must comply with various federal and state regulations, including the Good Clinical Practice Regulations. Facilities inspections and quality assurance discussions may also be part of the negotiation process.
    D-COHRe Strategic Partnership Solicitation.pdf
    The U.S. Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), announced a solicitation for strategic partnerships to enhance decentralized clinical operations (D-COHRe) aimed at modernizing clinical trials and improving healthcare infrastructure in response to public health emergencies. The program seeks partners that can provide decentralized healthcare services, with an emphasis on utilizing retail pharmacies, telemedicine, and urgent care to facilitate patient access to clinical studies for medical countermeasures. Selected partners will engage in capability-building efforts to support sustainable decentralized trial models while adhering to governance and financial guidelines as outlined in the solicitation.
    DCOHRe Strategic Partnership Solicitation.pdf
    The U.S. Department of Health and Human Services is soliciting strategic partnerships with organizations providing decentralized healthcare services to enhance clinical research capabilities. The goal is to stimulate the expansion of decentralized clinical study capabilities and validate products and technologies intended for use in decentralized settings. The partnerships will focus on product development, product adoption and utilization, and clinical trial innovation.
    Lifecycle
    Title
    Type
    Decentralized Clinical Operations for Healthcare and Research (D-COHRe)
    Currently viewing
    Solicitation
    Similar Opportunities
    DRAFT Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) exploration topic. This initiative aims to enhance access to curative cell therapies for pediatric patients with rare genetic diseases by developing novel quality assurance mechanisms at Academic Medical Centers (AMCs) over a structured 24-month program. The program will focus on identifying manufacturing variability, improving batch quality through signature identification methodologies, and creating statistical tools to guide production decisions, ultimately streamlining the development of small batch autologous cell therapies. Proposals are due by October 22, 2024, and interested parties should direct inquiries to the designated email address provided in the solicitation.
    RRPV Solicitation Summary: NextGen Oral Formulation Vaccines for COVID-19
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response (BARDA), is seeking proposals for the development of NextGen Oral Formulation Vaccines for COVID-19 through a Request for Project Proposals (RPP) issued via the Rapid Response Partnership Vehicle (RRPV) Consortium. The primary objective of this solicitation is to advance oral vaccine platforms and technologies into a proof-of-concept Phase 1 clinical trial, enhancing the understanding of their potential and improving COVID-19 solutions to bolster preparedness against future health security threats. This initiative is critical in the ongoing efforts to combat COVID-19 and prepare for similar health crises. Interested parties can access the full RPP and additional consortium information at www.rrpv.org, and inquiries can be directed to Rebecca Harmon at rebecca.harmon@ati.org.
    RRPV Solicitation Summary: On-Demand Manufacturing
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response (ASPR) through the Biomedical Advanced Research and Development Authority (BARDA), is seeking proposals for the "On-Demand Manufacturing" initiative under the Rapid Response Partnership Vehicle (RRPV) Consortium. The objective of this solicitation is to advance manufacturing technologies that enhance access and enable the rapid, cost-effective, and flexible production of vaccines and other biologics through decentralized manufacturing strategies. This initiative is crucial for improving the responsiveness of the healthcare system in times of need, particularly in the context of public health emergencies. Interested parties can find more information and access the full Request for Project Proposals (RPP) at the RRPV website, and inquiries can be directed to Rebecca Harmon at rebecca.harmon@ati.org.
    HEalth care Rewards to Achieve Improved OutcomES (HEROES)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the HEalth care Rewards to Achieve Improved OutcomES (HEROES) program, aimed at enhancing community health outcomes via innovative, community-based interventions. This initiative seeks to implement a payment model that incentivizes positive health outcomes across four critical areas: maternal health, heart attack and stroke risk, opioid overdose, and alcohol-related health harms, particularly in underserved populations. The program is significant as it aims to address health disparities and improve public health metrics while reducing the overall healthcare burden. With a total funding amount of $99 million available over three years, interested parties must submit their Solution Summaries by the specified deadlines, with full proposals due in November 2024. For further inquiries, proposers can access the ARPA-H Ask-A-Question platform for technical or administrative questions.
    COVID-19 Small Molecule Therapeutics for PrEP
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is seeking proposals for the "COVID-19 Small Molecule Therapeutics for PrEP" initiative. This opportunity invites qualified offerors to submit project proposals via the Rapid Response Partnership Vehicle (RRPV) Consortium, aimed at developing therapeutics for pre-exposure prophylaxis against COVID-19. The initiative is critical in enhancing public health responses and preparedness against the ongoing pandemic. Interested parties can access the full Request for Project Proposals and additional consortium information at www.rrpv.org, and inquiries can be directed to Rebecca Harmon at rebecca.harmon@ati.org.
    The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Partners for Clinical Research Collaborations on Therapeutics, Diagnostics or Devices for the Liver Cirrhosis Network
    Active
    Health And Human Services, Department Of
    Special Notice HEALTH AND HUMAN SERVICES, DEPARTMENT OF seeks industry partners for clinical research collaborations on therapeutics, diagnostics or devices for the Liver Cirrhosis Network. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is looking for industry collaborators to provide novel or repurposed therapeutic agents, diagnostic markers, biomarkers, devices, or services for use in NIH-sponsored multi-center clinical trials and ancillary studies in adult patients with advanced liver disease and cirrhosis. The Liver Cirrhosis Network aims to promote clinical and translational research on cirrhosis of the liver and related complications in adults. The network is interested in conducting research that will lead to improved clinical outcomes in adults with cirrhosis and advanced liver disease. Commercial organizations interested in pursuing clinical collaborations with NIDDK for cirrhosis liver disease are required to submit a Capability Statement to the NIDDK.
    A--Request for Proposals - Phase I Clinical Trials
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Phase I clinical trials aimed at developing small molecule and biologics therapeutics, as outlined in RFP No. 75N95024R00086. The selected contractor will be responsible for comprehensive services including protocol development, trial management, and reporting to regulatory agencies, with a focus on safety, tolerability, and pharmacokinetics of the investigational therapeutics. This initiative is crucial for advancing therapeutic development in the field of neurology, ensuring compliance with FDA and ICH GCP standards throughout the trial process. Proposals are due by October 3, 2024, with a contract performance period from April 1, 2025, to March 31, 2035, and a maximum contract value of $233,227,446. Interested parties can contact Evan C. Feely at evan.feely@nih.gov or +1 301 827 5301 for further information.
    Strengthening DHS Collaboration with Local Health Partners
    Active
    Homeland Security, Department Of
    The Department of Homeland Security (DHS) intends to award a sole source contract to the National Association of County and City Health Officials (NACCHO) to enhance collaboration with local health partners for health security preparedness. The contract aims to engage over 3,000 local health departments nationwide, focusing on addressing challenges related to chemical, biological, radiological, and nuclear threats, while also considering the impacts of climate change and migrant public health needs. This initiative is crucial for establishing a cohesive operational framework that enhances coordination among health officials, emergency services, and federal initiatives. Interested parties may submit their interest and capability to meet this requirement by September 19, 2023, at 10:00 AM Eastern Time, with responses directed to Contract Specialist Leatrice A. Bulls and Contracting Officer Marcus Datcher via email.
    Sources Sought (SS) | World Trade Center Health Program | Survivor Clinical Center of Excellence
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Centers for Disease Control and Prevention (CDC), is seeking information from organizations interested in supporting the operationalization of a Clinical Center of Excellence (CCE) as part of the World Trade Center (WTC) Health Program. The objective is to identify potential contractors capable of providing monitoring and treatment services for eligible Survivor members affected by the September 11 terrorist attacks, with services required from July 1, 2025, to June 30, 2030. This initiative underscores the federal commitment to delivering comprehensive healthcare to 9/11 responders and survivors, emphasizing compliance, effective personnel management, and high-quality service delivery. Interested parties must submit their capability statements by October 2, 2024, and can direct inquiries to Melissa Lera at umt1@cdc.gov.
    Clinic Consortium for HIV Implementation on Research and Prevention (CCHIRP)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), has announced the cancellation of the pre-solicitation for the Clinic Consortium for HIV Implementation Research and Prevention (CCHIRP). This initiative aimed to address HIV implementation research and prevention strategies; however, due to current budgetary constraints, the funding for this requirement has been impacted, leading to the cancellation of Notice ID No. 75D301-24-R-72954. The government will reassess the requirement and may issue a new solicitation in the future if funding becomes available. For further inquiries, interested parties can contact Mark Wirtz at mag8@cdc.gov or Stephanie Reid at qs5@cdc.gov.