Open for applications

Federal funding opportunity

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institutes of Health

  • OpportunityPAR-27-064
  • Agency codeHHS-NIH11
  • CategoryDiscretionary (D)
1049 days until applications close Thu, July 5, 2029
PostedJun 16, 2026 ClosesJul 5, 2029
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Competitive proposals usually start 6+ weeks out.

N/a Est. program funding
N/a Award ceiling
N/a Award floor
N/a Expected no. of awards

Program summary

Synopsis

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Timeline

Key dates

  • June 16, 2026
    Opportunity posted to grants.gov
  • August 21, 2026
    Today — 1049 days of the window remain
  • July 5, 2029
    Applications close
  • September 5, 2029
    Opportunity archived

Who may apply

Eligibility

Eligible applicant types as published by the awarding agency:

  • Private institutions of higher education
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • County governments
  • City or township governments
  • State governments
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • For profit organizations other than small businesses
  • Special district governments
  • Native American tribal governments (Federally recognized)
  • Public and State controlled institutions of higher education
  • Small businesses
Additional info on eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Cost sharing or matching
Not required

Awarding agency

Additional information

Agency name
National Institutes of Health
Grantor contact
National Institutes of Health
301-402-2541
NIAID_IICT_U01@mail.nih.gov

Assistance listing

CFDA program(s)

  • 93.855 Allergy and Infectious Diseases Research

Government Grants Consulting

Federal, state, and local grant funding is highly competitive, and the gap between a complete application and a winning one usually comes down to strategy, compliance, and execution. GTC 360° Advisors supports organizations across the entire grant lifecycle — from identifying the right opportunities to managing the award long after it is won. The questions below cover how our grant consulting practice works and the organizations we serve.

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    Government grant consulting means guiding an organization through the full grant lifecycle — research, eligibility review, strategy, writing, submission, and post-award compliance. GTC 360° Advisors manages this end to end, pairing grant writers, project managers, financial analysts, and compliance analysts to maximize the odds of an award and keep it in good standing afterward.

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    GTC 360° Advisors supports municipalities, state agencies, nonprofits, school districts, tribal governments, higher education institutions, and private companies pursuing grant funding. Clients have included the City of Los Angeles, Texas A&M University, the Montana State University System, Virginia Commonwealth University, and nonprofit partners such as the Walton Family Foundation and Blue Meridian Partners.

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    GTC 360° Advisors has secured funding from agencies including the Departments of Energy, Transportation, Housing and Urban Development, Agriculture, Health and Human Services, Commerce (EDA and NIST), Education, and State, as well as FEMA, EPA, NSF, NIH, HRSA, SAMHSA, and the CDC. The firm has won over $860 million and counting in federal and state contracts and grants for its clients.

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    GTC 360° Advisors has historically maintained an 88%-plus win rate on the grant applications it has submitted, including a 100% win rate in 2024 across several highly competitive programs. Recent wins include $180 million in EDA Tech Hubs funding for three consortia and $20 million in EDA Recompete funding for the City of Birmingham, Alabama.

  • Can nonprofits and higher education institutions work with GTC 360° Advisors on grants?

    Yes. GTC 360° Advisors regularly supports nonprofits and universities with grant strategy, writing, and administration, including current work with the Walton Family Foundation, Blue Meridian Partners, Texas A&M University, the Montana State University System, and Virginia Commonwealth University.

Working With GTC 360° Advisors

Every engagement is scoped around the organization in front of us — its goals, its deadline, and the internal capacity it already has. Pricing, team assignments, and project milestones are agreed before any work begins, so there are no surprises mid-project. Below are the questions prospective clients and partners ask us most often.

  • How much does it cost to work with GTC 360° Advisors?

    Pricing is customized to the scope, timeline, and budget of each engagement, with both hourly and fixed-fee options available depending on the deliverable. GTC 360° Advisors prices transparently, with no hidden fees for administrative or incidental work, and structures fees so clients gain a full team of senior professionals for less than the cost of a single in-house hire.

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    Engagements typically start with a conversation about your organization’s goals, funding needs, or growth targets, followed by a scoped proposal outlining services, team, and pricing. From there, GTC 360° Advisors assigns team members matched to the work and begins with research, strategy, or capture planning, depending on the engagement.

  • How long does it take to see results from a grant or contract engagement?

    Timelines vary by opportunity: some grant or contract cycles run a few months from research to submission, while others (large infrastructure or multi-year programs) take longer and continue through post-award management. GTC 360° Advisors sets clear project timelines and milestones at the start of every engagement so clients know what to expect.

  • Does GTC 360° Advisors work with organizations outside the United States?

    GTC 360° Advisors primarily supports U.S.-based government contracts, grants, and business development, but its public affairs and business development services extend internationally through its global partner network for clients running cross-border campaigns.

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    Yes. GTC 360° Advisors welcomes applications from experienced firms and freelancers who align with its mission and values to join the GTC 360° Advisors Network, giving members access to mutual marketing, referrals, and new client opportunities.

  • How do I contact GTC 360° Advisors to discuss a project?

    You can reach GTC 360° Advisors at info@gtc360.com or through the contact form at gtc360.com/join-our-network. The firm typically responds to discuss goals, funding needs, or growth targets and outline next steps for an engagement.

1049 days is enough time — if you start now.

Tell us the opportunity and we will come back with an honest read on fit, the partners you would need, and what a compliant submission takes.

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