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 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 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.
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 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 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 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 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.
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.
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.
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'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.
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.
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 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.
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.
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.