Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, August 19 at 2:00 PM EDT

Register Free →
logo
Get CLEATUS

Clinical Trial Design and Regulatory Strategy Consulting

Active
Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

Show more

The contract pertains to the development of clinical trial protocols and regulatory submission strategies essential for advancing medical products into human studies, with a focus on compliance with FDA regulations, Good Clinical Practice standards, and requirements for demographic inclusivity in trial populations. The work involves designing robust clinical trial frameworks, preparing submissions such as Investigational New Drug or Investigational Device Exemption applications, and ensuring all aspects of the development pathway meet federal regulatory expectations for safety, efficacy, and ethical conduct. This is a subcontract under the Department of the Army’s U.S. Army Medical Research and Acquisition Activity, operating within the broader Department of Defense framework, with a NAICS code of 541611 indicating it falls under scientific research and development services. The opportunity was posted on June 17, 2026, with responses due by November 4, 2026, and the place of performance is not specified, allowing for potential remote or distributed execution. The scope demands deep expertise in regulatory affairs and clinical development to support the transition from preclinical to human trial phases, emphasizing strategic planning and adherence to rigorous compliance standards.

General Info

Develop clinical trial protocols and regulatory submissions for FDA-compliant, inclusive human studies under DoD subcontract.

Agency

Department Of Defense → Department Of The Army -- UsamraaView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of HT942526BMFRPIIRA.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

DoW Bone Marrow Failure, Investigator-Initiated Research Award

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

Cannot generate Contract Breakdown because no documents were found from this contract's source.

Timeline

Posted

subcontract

Response Deadline

Submission deadline

Response Deadline

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more
AgencyDepartment Of Defense → Department Of The Army -- Usamraa
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → Department Of The Army -- Usamraa
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Develop clinical trial protocols, regulatory submission strategies (e.g., IND/IDE), and ensure compliance with FDA, GCP, and demographic inclusion requirements for transition to human studies.

Similar Contracts

Same NAICS industry code

NAICS: 541611
New
SLED
Grant Compliance and Guidelines ReviewThe Grant Compliance and Guidelines Review subcontract, issued by the Mississippi Department of Health, focuses on ensuring all grant submissions strictly adhere to funder-specific rules, formatting, and content requirements. The primary objective is to conduct thorough internal reviews to mitigate the risk of grant rejections caused by non-compliance. This opportunity was posted on August 17, 2026, with a response deadline of September 17, 2026. Classified under NAICS code 541611, the contract is designed to provide specialized administrative and professional support to ensure the quality and eligibility of grant applications.
MS DEPT of HEALTH

POSTED

1 day ago

DEADLINE

in 30 days
View Details
NAICS: 541611
New
SLED
Grant Research and Funding Opportunity IdentificationThe Mississippi Department of Health is seeking a subcontractor for Grant Research and Funding Opportunity Identification under NAICS code 541611. The primary objective of this contract is to identify and compile a comprehensive list of federal, state, local, and private grant opportunities that align with MSDH public health programs. The selected provider will be responsible for maintaining a detailed database that tracks critical information, including application deadlines, eligibility requirements, and the specific priorities of various funders. The solicitation was posted on August 17, 2026, with a response deadline of September 17, 2026.
MS DEPT of HEALTH

POSTED

1 day ago

DEADLINE

in 30 days
View Details
NAICS: 541611
New
SLED
Change Management & Clinical Workflow OptimizationThe University of Mississippi Medical Center is seeking a subcontractor for a project focused on Change Management and Clinical Workflow Optimization. The primary objective of this engagement is to support UMMC in optimizing clinical scheduling workflows and improving user adoption of the QGenda platform, particularly during system updates or enhancements. This opportunity falls under NAICS code 541611 and was posted on August 17, 2026, with a response deadline of August 31, 2026. The contract aims to ensure a seamless organizational transition and operational efficiency through strategic change management and workflow improvements.
UNIV of MS MEDICAL CENTER

POSTED

1 day ago

DEADLINE

in 13 days
View Details
NAICS: 541611
New
DIBBS
Fuel Delivery Site Access and Security Vetting CoordinationThis subcontract, titled Fuel Delivery Site Access and Security Vetting Coordination, is issued by the Defense Logistics Agency under the Department of Defense. The primary objective of the contract is to manage driver access credentials to ensure continuous site access compliance, specifically through the verification of TWIC credentials and the processing of SECNAV Form 5512/1. The work falls under NAICS code 541611 and was posted on August 17, 2026. This effort focuses on the security vetting and administrative coordination required to maintain authorized entry for fuel delivery personnel at designated sites.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Technical Data Management and Export-Controlled Information HandlingThis subcontract, issued by the Defense Logistics Agency under the Department of Defense, focuses on the management, storage, and access control of technical data for C-130 AC PBL components. The primary objective is to ensure strict compliance with ITAR/EAR and DFARS export control requirements to protect sensitive information. Classified under NAICS code 541611, the agreement establishes the protocols necessary for handling export-controlled information. The contract was posted on August 17, 2026, and is managed through the DLA's procurement systems to maintain the integrity and security of technical data associated with these specific aircraft components.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Obsolescence and Discontinuance Notification ServicesThis subcontract, titled Obsolescence and Discontinuance Notification Services, is issued by the Defense Logistics Agency under the Department of Defense. The primary objective of the agreement is to ensure the monitoring and reporting of any planned phase-outs of materials or manufacturing methods, as specifically mandated by contract Clause C02. The contract is categorized under NAICS code 541611 and was posted on August 17, 2026. It establishes a formal requirement for the contractor to provide notification services regarding the obsolescence of critical components to maintain operational readiness and supply chain stability.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Supply Chain Traceability Documentation ServicesThe Defense Logistics Agency within the Department of Defense has established a subcontract for Supply Chain Traceability Documentation Services. This agreement focuses on the maintenance and delivery of audit-ready traceability records for all raw materials and production components used throughout the supply chain. Classified under NAICS code 541611, the contract was posted on August 17, 2026. The primary objective is to ensure rigorous documentation standards are met to support compliance and auditing requirements for the agency.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Export Control & Technical Data ManagementThis subcontract opportunity with the Department of Defense, specifically LSO Combat Vehicles and Armament, focuses on the management of ITAR and EAR controlled technical data. The primary objective is to ensure strict compliance with the US and Canada Joint Certification Program requirements. The project is designated as a total small business set-aside under FAR 19.5, utilizing NAICS code 541611. Interested parties must submit their responses by September 1, 2026, following the posting date of August 17, 2026.
LSO COMBAT VEHICLES AND ARMAMENT

POSTED

1 day ago

DEADLINE

in 14 days
View Details
NAICS: 541611
New
DIBBS
Supply Chain Risk Management (SCRM) and Foreign Ownership DisclosureThis subcontract with the Defense Logistics Agency under the Department of Defense focuses on Supply Chain Risk Management and Foreign Ownership Disclosure. The primary objective is to conduct comprehensive supply chain audits to ensure strict compliance with NDA Andean Section 889 and DFARS 252.209-7002, specifically targeting the identification of prohibited telecommunications equipment and the disclosure of foreign ownership. Classified under NAICS code 541611, the contract emphasizes the mitigation of security risks within the supply chain to protect national security interests. The scope of work involves verifying that all components and partners adhere to federal regulations regarding foreign influence and the use of banned technology.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Defense-Related Telecommunications Equipment Disclosure SupportThis subcontract, titled Defense-Related Telecommunications Equipment Disclosure Support, is issued by the Department of Defense under the Land Supply Chain agency. The primary objective of the contract is to provide administrative support to ensure compliance with disclosure requirements regarding covered defense telecommunications equipment. This includes the critical reporting of Unique Entity Identifiers and CAGE codes for all participating entities. The opportunity was posted on August 17, 2026, with a response deadline of August 28, 2026. Classified under NAICS code 541611 for administrative management and consulting services, the place of performance is located at FPO 96349. Interested parties can find further details through the provided DIBBS solicitation link.
LAND SUPPLY CHAIN

POSTED

1 day ago

DEADLINE

in 10 days
View Details
NAICS: 541611
New
DIBBS
Domestic Sourcing and Supply Chain ComplianceThis subcontract with the Defense Logistics Agency under the Department of Defense focuses on domestic sourcing and supply chain compliance. The primary objective is to ensure strict adherence to the Buy American Act and the Berry Amendment by implementing rigorous supply chain traceability and maintaining detailed origin documentation. The agreement is categorized under NAICS code 541611 for professional services and was posted on August 17, 2026. It establishes the necessary frameworks for verifying that materials and components meet federal domestic sourcing requirements to support national defense procurement standards.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541611
New
DIBBS
Small Business Subcontracting Compliance and AdministrationThis subcontract, titled Small Business Subcontracting Compliance and Administration, is issued by the Defense Logistics Agency under the Department of Defense. The primary objective of the agreement is to provide consulting services that support the prime contractor's Women-Owned Small Business subcontracting plan. The scope of work focuses on the tracking, reporting, and overall compliance with FAR and DFARS requirements. Classified under NAICS code 541611, the contract ensures that all regulatory obligations regarding small business participation are met and documented accurately.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details

More opportunities from Department Of Defense → Department Of The Army -- Usamraa

Same awarding agency

NAICS: 561510
Grant
Travel Coordination for Multi-Institutional CollaborationThe contract establishes a subcontract to manage travel logistics for up to three investigators annually to attend one scientific meeting per year, with allowable direct costs covered under the associated grant. This arrangement supports multi-institutional collaboration by ensuring coordinated, compliant, and efficient travel arrangements for key personnel involved in federally funded research. The work is classified under NAICS code 561510, indicating it involves travel arrangement and related services, and is administered by the Department of the Army through the U.S. Army Medical Research and Acquisition Activity under the broader Department of Defense. The opportunity was posted on June 17, 2026, with a response deadline of November 18, 2026, allowing interested parties sufficient time to prepare proposals. While no specific location of performance or point of contact is provided, the contract is intended to facilitate participation in scientific meetings critical to the advancement of research goals under the grant. The subcontract is not subject to any set-aside requirements and must adhere strictly to federal grant guidelines regarding allowable travel expenses. All logistics must be handled with transparency, cost-effectiveness, and alignment with the sponsor's mission to promote collaborative scientific progress.
Travel Agencies

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541990
Grant
Dissemination and Knowledge Translation ServicesThe contract seeks to develop and execute a strategic plan for disseminating research findings to scientific, clinical, and patient communities through publications, conference presentations, and digital content platforms. The work is classified as a subcontract under NAICS code 541990, indicating it falls under other professional, scientific, and technical services, and is being managed by the Department of the Army through the U.S. Army Medical Research and Acquisition Activity, under the broader Department of Defense. The goal is to ensure that research outcomes reach diverse audiences effectively, promoting translation of scientific knowledge into practical applications and informed decision-making. The opportunity was posted on June 17, 2026, with a response deadline of November 18, 2026, and does not specify a set-aside status or detailed location for performance. All activities must align with the mission of advancing public health and medical science through targeted communication strategies tailored to different stakeholder groups.
All Other Professional, Scientific, and Technical Services

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 813930
Grant
Patient Advocacy and Community Engagement CoordinationThe contract seeks to establish and manage partnerships between researchers and patient advocacy groups to enhance collaboration in health-related initiatives, with a focus on building sustainable community engagement structures and actionable engagement plans. It emphasizes the development of frameworks that ensure meaningful involvement of patient communities in research processes, aiming to align scientific objectives with real-world patient needs and perspectives. The effort is designed to foster trust, improve communication, and integrate community input into the design and implementation of research activities under the purview of the Department of Defense. This subcontract, issued under NAICS code 813930 by the Department of the Army through USAMRAA, is open for responses until November 18, 2026, with no specific set-aside provisions indicated. The work does not specify a physical place of performance, suggesting flexibility in execution, potentially across multiple locations or virtually. The initiative is part of broader efforts within the Department of Defense to strengthen public health relationships and ensure that research outcomes are both scientifically rigorous and socially resonant. Participation requires demonstrated expertise in bridging academic research with community advocacy, and the ability to create scalable, inclusive engagement models that empower patient voices throughout the research lifecycle.
Labor Unions and Similar Labor Organizations

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541690
Grant
Scientific Peer Review and Grant Evaluation ServicesThe contract entails providing scientific peer review and grant evaluation services for the Department of the Army through USAMRAA, focusing on the thorough assessment of grant applications across key domains including scientific impact, personnel qualifications, research approach, and the integration of patient advocacy. Evaluators are expected to apply rigorous, evidence-based standards to determine the quality and potential of proposed projects, ensuring alignment with organizational priorities and the advancement of mission-critical health and medical research. The work demands expertise in biomedical and clinical sciences, as well as a demonstrated ability to evaluate the meaningful incorporation of patient perspectives into study design and implementation. This subcontract is open for responses until November 18, 2026, and falls under the NAICS code 541690 for other scientific and technical consulting services. While the solicitation number and point of contact are not specified, the opportunity is posted under the Department of Defense and requires contractors to be prepared for federal grant review protocols. The place of performance and office address details are undefined, suggesting that the work may be performed remotely or across multiple locations, with evaluation tasks managed electronically through the Grants.gov portal. Participation requires a strong background in peer review processes and familiarity with the standards of scientific merit and translational relevance in federally funded research.
Other Scientific and Technical Consulting Services

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541611
Grant
Regulatory Compliance and Ethics Review SupportThe contract seeks a subcontractor to provide comprehensive regulatory compliance and ethics review support for research activities under the Department of Defense, specifically focusing on submissions to Institutional Review Boards, Institutional Animal Care and Use Committees, and other ethics review bodies. The primary responsibility includes ensuring all research protocols adhere to Department of Defense regulations and secure necessary approvals, particularly from the Defense Health Agency Office of Research Oversight and Regulatory Compliance. This work requires deep expertise in navigating federal research ethics frameworks and maintaining strict adherence to DoD standards throughout the lifecycle of research projects. The subcontract is open for proposals with a response deadline of November 18, 2026, and is classified under NAICS code 541611, indicating it pertains to management, scientific, and technical consulting services. The work is associated with the U.S. Army Medical Research and Acquisition Activity under the Department of Defense, though no specific location is designated for performance. The nature of the contract implies that the selected entity will serve in a critical advisory and compliance role, supporting the integrity and legal standing of military-funded research by managing documentation, coordination, and regulatory alignment across multiple oversight entities. No set-aside provisions are in place, making eligibility open to all qualified parties regardless of business size or ownership category.
Administrative Management and General Management Consulting Services

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541611
Grant
Biospecimen Repository and Management ServicesThe contract titled Biospecimen Repository and Management Services aims to establish and maintain secure, high-quality repositories for biospecimens including tissue and blood samples, specifically to support rare cancer research. These repositories must be accurately linked to comprehensive clinical data to enable meaningful analysis and advance scientific understanding of uncommon cancers. The work involves the end-to-end management of specimen collection, processing, storage, and retrieval under strict regulatory and quality standards to ensure data integrity and sample viability over time. The subcontract will require robust infrastructure and protocols for tracking, documentation, and compliance with ethical and privacy guidelines applicable to human biospecimens. The opportunity is posted by the Department of the Army through the U.S. Army Medical Research and Acquisition Activity under the Department of Defense and is classified under NAICS code 541611 for scientific research and development services. It was published on June 17, 2026, with a response deadline of November 18, 2026. The contract is structured as a subcontract and does not specify any set-aside categories or geographic restrictions for performance. While the exact location of performance and point of contact are not provided, the work is expected to support federal research priorities in oncology and may involve collaboration with clinical and research institutions. Interested parties must submit proposals prior to the deadline to be considered for award.
Administrative Management and General Management Consulting Services

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541715
Grant
Rare Cancer Research Data Platform DevelopmentThe contract seeks the design and implementation of technical and organizational platforms dedicated to the collection, sharing, and analysis of rare cancer clinical and preclinical datasets. It is issued as a subcontract under the Department of the Army through USAMRAA, with the NAICS code 541715 indicating it falls under research and development in the biological sciences. The goal is to establish a robust infrastructure that enables secure, standardized, and interoperable handling of complex cancer data across research institutions, supporting accelerated discovery and collaboration in oncology research. The platform must integrate advanced data management protocols, ensure compliance with data privacy and security standards, and facilitate analytical capabilities tailored to the unique challenges of rare cancer datasets. The opportunity was posted on June 17, 2026, with a response deadline of November 18, 2026. There is no specified set-aside designation or geographic restriction for performance, and no point of contact details are provided in the solicitation. The work is expected to require expertise in bioinformatics, data governance, cloud-based infrastructure, and clinical research systems, with a focus on interoperability and scalability. The absence of a place of performance assignment suggests the project may involve distributed collaboration across multiple locations or remote delivery. Interested parties must respond by the deadline to be considered for this subcontract under the Department of Defense’s broader mission to advance rare cancer research through data-driven innovation.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

2 months ago

DEADLINE

in 3 months
View Details
NAICS: 541611
Grant
Regulatory & Compliance Consulting for DoD-Funded ResearchThe contract seeks expert consulting services to ensure full regulatory compliance for research funded by the Department of Defense, with a focus on intricate processes such as Institutional Review Board and Institutional Animal Care and Use Committee submissions, disclosures required under National Security Presidential Memorandum 33, and adherence to the Department of Defense Grant and Agreement Regulations. The scope centers on providing specialized guidance to navigate complex federal requirements, helping recipients maintain legal and ethical standards while advancing federally supported research initiatives. The contract is structured as a subcontract under the Department of the Army through USAMRAA, operating within the broader Department of Defense framework, and is aligned with NAICS code 541611 for management consulting services. The posting date is June 17, 2026, with responses due by September 16, 2026. While the place of performance and specific point of contact details are not provided, the work is anticipated to support DoD-funded projects requiring stringent oversight and documentation, emphasizing proactive compliance and risk mitigation in sensitive research environments.
Administrative Management and General Management Consulting Services

POSTED

2 months ago

DEADLINE

in 28 days
View Details
NAICS: 518210
Grant
Data Management & Research Resource Repository SupportThe contract seeks a subcontractor to develop and maintain secure, compliant systems for managing and sharing research data under the direction of the CDMRP data sharing directive. Core responsibilities include implementing metadata tagging protocols and establishing public access frameworks that ensure transparency, integrity, and security of research data while meeting federal requirements. The work must support seamless data discoverability and usability for authorized users and the broader scientific community, with emphasis on adherence to standardized data management practices. The opportunity is classified under NAICS code 518210 and is issued by the Department of Defense through the U.S. Army Medical Research and Acquisition Activity. While the solicitation number is not provided, the posting date is June 17, 2026, with a response deadline of September 16, 2026. Performance location details are unspecified, and no set-aside provisions or point of contact information are included in the available data. The project is positioned as a subcontract and is accessible via the Grants.gov portal.
Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

POSTED

2 months ago

DEADLINE

in 28 days
View Details
NAICS: 541380
Grant
Pre-Clinical & Laboratory Testing ServicesThe contract titled Pre-Clinical & Laboratory Testing Services is issued by the Department of the Army through USAMRAA under the Department of Defense and seeks specialized laboratory services to support VCA research. The scope includes immune monitoring, histopathology, biomarker analysis, and graft viability testing using biological specimens derived from animal or human sources. These services are critical for advancing transplant-related research and evaluating the biological responses and functional integrity of vascularized composite allografts in pre-clinical settings. The work is expected to be performed under a subcontract structure and is classified under NAICS code 541380, which corresponds to other scientific research and development services. The solicitation was posted on June 17, 2026, with a response deadline of September 16, 2026. There is no specified set-aside designation or city/state details for the place of performance, and no point of contact information has been provided. The contract does not include detailed location specifications for service delivery, suggesting that performance may be conducted at the vendor’s facility or a designated research site with appropriate biosafety and analytical capabilities. Interested parties must submit proposals before the stated deadline to be considered for award.
Testing Laboratories and Services

POSTED

2 months ago

DEADLINE

in 28 days
View Details
NAICS: 541715
Grant
Vascularized Composite Allotransplantation (VCA) Research & DevelopmentThe contract pertains to advanced research and development in vascularized composite allotransplantation, focusing on high-risk, high-reward scientific objectives that include surgical innovation, immunomodulation strategies, and tissue integration mechanisms. The work demands the development of novel techniques and methodologies aimed at improving transplant outcomes, with deliverables structured around clearly defined milestones that require rigorous data collection and transparent research resource sharing to ensure scientific advancement and reproducibility. This subcontract is issued by the Department of the Army through USAMRAA under the Department of Defense, targeting cutting-edge biomedical science within the NAICS code 541715, which classifies research and development in the physical, engineering, and life sciences. The opportunity was posted on June 17, 2026, with a response deadline of September 16, 2026, indicating a tight window for proposers to submit comprehensive research plans. While no specific set-aside provisions or location details are provided, the place of performance and point of contact remain undefined, suggesting the work may be conducted at the awardee’s facility or a collaborative research environment aligned with the Department of Defense’s strategic goals. The emphasis on data-driven milestones and resource sharing reflects a commitment to open scientific progress, ensuring that breakthroughs contribute broadly to the field of transplant medicine and serve national defense and medical readiness objectives.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

2 months ago

DEADLINE

in 28 days
View Details
NAICS: 541611
Grant
Technology Transfer and Research Outcomes PlanningThe contract seeks the development of a one-page research outcomes plan centered on the strategic dissemination of research findings, a clear publication strategy, and the potential translation of results into military or civilian medical applications. The work must concisely outline how the research will be shared with relevant stakeholders, including academic, clinical, and operational audiences, while identifying pathways for real-world implementation in both defense and public health contexts. Emphasis is placed on ensuring that outcomes are actionable and scalable, with consideration for timelines, intellectual property considerations, and engagement with end users in medical and military settings. The solicitation is classified as a subcontract under NAICS code 541611, issued by the Department of the Army through the U.S. Army Medical Research and Acquisition Activity, under the broader Department of Defense. Proposals must be submitted by September 18, 2026, and the work is expected to be performed without a specified physical location, allowing for remote execution. There is no set-aside designation, meaning the opportunity is open to all eligible entities. The focus is on creating a concise, high-impact document that bridges the gap between research and practical application, ensuring the technology or findings can be rapidly adopted to enhance medical readiness or civilian healthcare performance.
Administrative Management and General Management Consulting Services

POSTED

2 months ago

DEADLINE

in about 1 month
View Details