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NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

List of Required Information for Application:

1. Small business concern (SBC) information

2. Project title

3. Project summary/abstract

4. Proposed budget

5. Project timeline/schedule

6. Clinical trial design and objectives

7. Clinical trial protocol

8. Identification of high-risk features in the study

9. Justification for high-risk clinical studies

10. Proposed interventions or administration of products

11. Licensing status of products being used

12. Indication for the use of a licensed product for an unapproved indication

13. Mechanistic study proposal, if applicable

14. Milestones for the project

15. Expected outcomes and impact of the clinical trial

16. Previous research or preliminary data supporting the proposed study

17. Relevant expertise and experience of the project team

18. Potential risks and mitigation strategies

19. Ethical considerations and protection of human subjects, if applicable

20. Institutional review board (IRB) approval status, if applicable

21. Data management and analysis plan

22. Dissemination plan for the results of the clinical trial

23. Letters of support or collaboration from other organizations or investigators

24. Biosketches of key personnel involved in the project

25. Financial disclosures and conflicts of interest

26. Compliance with FDA regulations and guidelines, if applicable

27. Any additional supporting documents or appendices as required by the funding opportunity announcement.

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Funding Amount

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Eligible Applicants

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Eligible Activities

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Deadline to Apply

Apply for Funding

88%

Approval rating across all Canadian funding programs

93%

Average time savings to our clients, compared to
businesses that apply for funding in-house
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