Module 1
Project Overview & Team
Provide the foundational details of your project. This information populates the Cover Page, Project Summary/Abstract, and Project Narrative.
📄 NIH: Project Summary/Abstract · Project Narrative · Cover Page
SBIR/STTR Phase I Budget cap is $314,363 total costs for 6–24 months. Focus on establishing feasibility and commercial potential. The PI must have >50% employment at the small business (SBIR) or at either the small business or research institution (STTR).
SBIR/STTR Phase II Budget cap is $2,095,748 total costs for 24–36 months. You must have received a Phase I award (or demonstrate equivalent prior work for Direct-to-Phase II). Focus on advancing toward a market-ready product.
SBIR/STTR Fast Track Combines Phase I and Phase II in a single submission reviewed together. Total budget can exceed $2.4M over ~3 years. Requires a fully developed Phase II plan and explicit Go/No-Go milestones at the time of submission.
Maximum 81 characters. Be specific and descriptive — reviewers read this first.
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Full name and highest degree(s). For SBIR/STTR, the PI must have primary employment (>50%) at the small business (SBIR) or at either the small business or research institution (STTR).
For SBIR/STTR: primary applicant is the small business. For STTR: also name the partnering research institution.
30-line limit (~250 words). Describe the problem, your approach, and expected impact. Written for a general scientific audience. Do not include proprietary or confidential information.
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2–3 sentences maximum. Explain the relevance of this research to public health in plain language for a lay audience.
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Proposed start date, total duration, and total direct costs requested. For Fast Track, use the combined total.
Start Date
Duration
Total Direct Costs
Module 1 of 8
Module 2
Specific Aims
The most critical page of your application (1 page limit). State the problem, your central hypothesis, and the 2–4 aims you will pursue to test it.
📄 NIH: Specific Aims (1-page attachment)
Phase I Focus: Aims should be narrow and feasibility-oriented. Typically 2–3 aims. Reviewers want to see that you can establish proof-of-concept within the Phase I budget and timeline.
Phase II Focus: Aims should build directly on Phase I results. Typically 3–4 aims. Reviewers expect you to reference Phase I milestones that were met and explain how Phase II will advance toward commercialization.
Fast Track Focus: Aims must be organized in two groups — Phase I aims (feasibility) and Phase II aims (development). Clearly indicate which aims belong to each phase. Go/No-Go milestones separating the phases are required (see Module 5).
1–2 sentences. State the gap in knowledge, unmet clinical need, or technical challenge your project addresses. This is the "hook" for reviewers.
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1 sentence. What is the overarching scientific or translational goal of your research program (beyond this grant)?
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1–2 sentences. State your testable, falsifiable central hypothesis. Describe the preliminary data or rationale that led you to it.
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▼ Phase I Aims (Feasibility) — Enter your Phase I aims below. Phase II aims will be entered separately.
Enter each aim with a concise title and a brief description of the rationale and approach. Use the + Add Aim button to add more.
1–2 sentences. What will successful completion of these aims establish, and what is the broader impact?
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Module 2 of 8
Module 3
Significance
Explain why the problem is important, what is currently known, and what critical gaps your project will address. For SBIR/STTR, also establish the commercial opportunity.
📄 NIH: Research Strategy – Section 1: Significance
Phase I: Briefly establish the scientific and commercial significance. Reviewers understand this is early-stage; focus on the size of the unmet need and why your approach is promising.
Phase II: Provide a more thorough treatment of significance, including updated literature and market data. Reference how your Phase I results have refined your understanding of the problem.
Fast Track: Significance must support both phases. Establish the scientific rationale for Phase I feasibility work AND the commercial significance that justifies the Phase II investment.
Summarize the current state of knowledge. What is known, and what critical gap does your project address? Cite key literature.
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What specific barriers, limitations, or knowledge gaps prevent progress in this field? Your project must directly address these.
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If your aims are achieved, how will the field be advanced? What new capabilities, knowledge, or tools will result?
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Module 3 of 8
Module 4
Innovation
Explain what is new and different about your approach. NIH reviewers look for conceptual and/or methodological novelty that challenges existing paradigms.
📄 NIH: Research Strategy – Section 2: Innovation
Phase I: Focus on the novelty of the concept and the technical approach. Explain why existing solutions are inadequate and how your approach is fundamentally different.
Phase II: Build on Phase I innovation narrative. Highlight how Phase I results validated your innovative approach and what additional innovations will be introduced in Phase II (e.g., new manufacturing process, novel regulatory strategy).
Fast Track: Address innovation at both the feasibility level (Phase I) and the development/commercialization level (Phase II). Explain how the combined approach is uniquely positioned to reach the market faster than a sequential Phase I → Phase II pathway.
What new concepts, methods, technologies, or applications does this project introduce? Use "This application is innovative because..." as a framing device.
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How does your approach improve upon or differ from current methods, products, or research directions?
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Module 4 of 8
Module 5
Approach & Research Plan
Describe your experimental design, methods, expected outcomes, and how you will handle potential pitfalls.
📄 NIH: Research Strategy – Section 3: Approach (6 pages Phase I; 12 pages Phase II/Fast Track)
Phase I — Research Strategy: 6 page limit. Focus on feasibility experiments. Describe the key experiments that will establish proof-of-concept. Reviewers expect concise, focused plans. Preliminary data is helpful but not required for Phase I.
Phase II — Research Strategy: 12 page limit. Provide a comprehensive experimental plan building on Phase I results. Include detailed methods, power calculations, and a robust timeline. Preliminary data (from Phase I) is required and should be prominently featured.
Fast Track — Research Strategy: 12 page limit (combined). The approach section must clearly delineate Phase I work (feasibility) from Phase II work (development). Go/No-Go milestones are required and will be used by NIH to decide whether to fund Phase II after Phase I completion.
Summarize your key preliminary findings that support the feasibility of your proposed work. For Phase I, even limited preliminary data strengthens your case. For Phase II/Fast Track, Phase I results are required.
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Provide an overview of your research design and the logic connecting your aims. Include a brief description of your model systems, key reagents, or platforms.
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For each aim, describe: (a) rationale, (b) specific experiments/tasks, (c) expected outcomes, and (d) potential pitfalls and alternative approaches.
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Describe the projected timeline for completing each aim. A Gantt-style description is acceptable. For Fast Track, show both Phase I and Phase II timelines.
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NIH requires explicit attention to scientific rigor. Describe your blinding strategy, statistical power, inclusion of both sexes, and steps to ensure reproducibility.
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Module 5 of 8
Module 6
Human Subjects, Ethics & Inclusion
NIH requires detailed information on the protection of human subjects, animal welfare, and the inclusion of diverse populations in research.
📄 NIH: PHS Human Subjects & Clinical Trials · Animal Welfare · Inclusion PolicyDoes your research involve human subjects? Select the appropriate category.
If human subjects are involved, describe risks, benefits, consent procedures, and privacy protections.
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NIH policy requires the inclusion of women and minorities. Describe your planned inclusion or justify any exclusions.
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If vertebrate animals are used, describe the species, numbers, justification, and procedures to minimize pain and distress.
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Module 6 of 8
Module 7
Team, Biosketches & Resources
Describe the qualifications of your team and the facilities available to carry out the proposed research. Reviewers assess whether you have the expertise and resources to succeed.
📄 NIH: Biographical Sketches (5 pages each) · Facilities & Other Resources · Equipment
Phase I: Reviewers want to see that the PI and team have the expertise to execute feasibility studies. For SBIR, emphasize the PI's entrepreneurial and scientific credentials. A lean team is acceptable for Phase I.
Phase II: A more complete team is expected. Include any new hires, consultants, or CRO/CMO partners needed for scale-up, regulatory work, or clinical studies. Show that the team has grown appropriately since Phase I.
Fast Track: Describe the team for both phases. Identify any team members who will be added for Phase II activities (e.g., regulatory affairs specialist, clinical operations lead). Letters of support from key collaborators strengthen the application.
Summarize the PI's relevant expertise, prior grant funding, and key publications that qualify them to lead this project. For SBIR/STTR, also describe entrepreneurial experience.
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List co-investigators, collaborators, and consultants. Describe each person's role and relevant expertise. For Phase II/Fast Track, include any CRO, CMO, or regulatory affairs partners.
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Describe the laboratory space, core facilities, equipment, and institutional resources available to support the proposed work. For SBIR/STTR, describe the small business's facilities.
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Module 7 of 8
Module 8
Budget, Data Sharing & Commercialization Plan
Provide a budget justification narrative, your data management and sharing plan, and your commercialization strategy.
📄 NIH: Budget Justification · Data Management & Sharing Plan · SBIR/STTR Commercialization Plan (12 pages, Phase II/Fast Track)
Phase I: Budget cap is $314,363 total costs. A brief commercialization potential section is expected but a full 12-page commercialization plan is NOT required for Phase I. Focus on justifying personnel, supplies, and equipment needed for feasibility experiments.
Phase II: Budget cap is $2,095,748 total costs. A full 12-page Commercialization Plan is REQUIRED. This is a major scored component. Reviewers look for a credible, detailed path to market including regulatory strategy, manufacturing plan, and funding strategy.
Fast Track: Provide separate budget justifications for Phase I and Phase II. A full 12-page Commercialization Plan is REQUIRED. The commercialization plan should address both the near-term (Phase II) and long-term (Phase III / post-NIH) funding and market strategy.
Justify each major budget category: personnel (effort and roles), equipment, supplies, travel, and other direct costs. For Fast Track, address Phase I and Phase II budgets separately.
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NIH requires a Data Management and Sharing (DMS) Plan for all applications. Describe what data will be generated, how it will be managed, and how/when it will be shared.
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List the key references cited throughout your application. Use a consistent citation format (e.g., Vancouver/NLM style).
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Module 8 of 8
Module 9
Commercialization Plan
Required for Phase II and Fast Track applications. Limited to 12 pages. Reviewers read this section first — before the research plan. A compelling commercialization plan demonstrates that your innovation has a clear, credible path from bench to market.
📄 NIH SF424 R&R SBIR/STTR Application Guide · Sections A–I · 12-page limit
Phase II: The Commercialization Plan is a scored section reviewed by the full study section. It must address all 9 NIH-required areas (A–I). Reviewers expect a realistic, evidence-based path to market. A weak commercialization plan can sink an otherwise strong application.
Fast Track: The Commercialization Plan must address both the near-term Phase II development milestones and the long-term Phase III / post-NIH commercialization strategy. Include separate financial projections for Phase II and post-NIH periods.
Provide a clear vision statement for the enterprise. Describe the overall goal, the product/service, the problem it solves, its advantages over competing approaches, commercial applications, non-commercial (societal/public health) impacts, and how this SBIR/STTR project integrates with your overall business plan. Include any history or past data that establishes the problem is real and significant.
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Describe your company's background, core competencies, and commercialization capabilities. Include: founding date, corporate objectives, current size and products/services, history of Federal and non-Federal funding, regulatory experience, and how the company plans to grow from a technology R&D firm to a successful commercial entity. Lead with business expertise (not scientific credentials).
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Define your market size (TAM → SAM → Target Market), identify your primary and secondary customer segments (end users vs. decision-making units), analyze competitors (strengths, weaknesses, market share), and describe your competitive advantage. Include data-supported market size estimates. Avoid overestimating market penetration.
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Summarize how you will protect the IP that enables commercialization. List current patents (granted or pending), describe your IP strategy, and explain how the IP creates a barrier to competitors. If no patents exist, describe your licensing strategy or other barriers (trade secrets, regulatory exclusivity, first-mover advantage).
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Describe your regulatory pathway to market. Specify the FDA submission type (510(k), PMA, De Novo, IND/NDA/BLA, CLIA waiver, etc.) and justify why that pathway applies. Include your timeline to regulatory clearance/approval, any pre-submission meetings planned or completed, and how you will address data compliance and security requirements.
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Describe your financing strategy for commercialization. Identify all sources of Phase III / post-NIH funding (private investors, VC, strategic partners, revenue, other grants). Provide financial milestones and timing. Evidence of investor interest (letters of commitment, LOIs) significantly strengthens this section. Include a brief revenue/cash flow projection.
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Describe how you will manufacture/produce your product at commercial scale (Product), your distribution channels (Place), your communications strategy (Promotion), and your pricing approach (Pricing). Address the 4 P's of marketing. Identify which customer segments to target first and how you will customize your market approach.
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Describe exactly how you plan to generate revenue from the product or service developed under this award. Include your revenue model, projected revenue timeline, and any existing revenue or letters of intent from early customers. Use charts or tables if helpful. Address whether the company is diversified or single-product.
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Use a SWOT framework to identify and address risks. Describe your company's internal Strengths and Weaknesses, and the external Opportunities and Threats. For each risk, provide a specific mitigation strategy. Reviewers want to see that you have thought critically about what could go wrong and have a plan.
✓ Strengths (Internal, Positive)
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⚠ Weaknesses (Internal, Negative)
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↗ Opportunities (External, Positive)
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▲ Threats (External, Negative)
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Mitigation Strategies
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Module 9 of 9
🤖 NIH Study Section Review Simulation
📋 About This Simulation
This tool simulates an NIH Dual-Panel Study Section review using two independent AI reviewer panels — The Bethesda Panel and The Rockville Panel — each comprising five reviewers with distinct scientific perspectives. The panels operate independently and their outputs are synthesized by a simulated Scientific Review Officer (SRO).
Each reviewer is assigned a named persona with a defined career background, institutional affiliation, and known evaluation biases. Scoring follows the NIH 1–9 scale (1 = Exceptional, 9 = Poor), calibrated against real NIH payline data. A score of 1–3 is typically fundable; 4–5 is discussed but near the payline; 6–9 is not competitive in most funding cycles.
The Reviewer Tone selector re-runs the full panel with tone-adjusted prompts — scores, language, and emphasis all change. The Scoring System toggle switches between the simplified 2025+ three-factor framework and the legacy five-criteria system.
⚠ Disclaimer: This is an AI simulation for educational and preparation purposes only. It does not represent the views of the National Institutes of Health or any federal agency. Scores and critiques are generated by large language models and may not accurately predict actual NIH review outcomes. Always consult your institution's grants office and program officer before submission.
Scoring System: