Solicitation
Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)
Department of Health and Human Services · National Institutes of Health · Sol. ARPA-H-SOL-26-164
Due in 51 days
Track this notice by email. We'll email you if it's amended or awarded, and a week and two days before responses are due.
AI summary Beta
ARPA-H (the federal health research agency) wants teams to build and run a clinical trial platform that combines computer simulation, real-time statistics and AI-run operations to speed up drug development in one disease area. It expects to award several Other Transaction agreements (a flexible research funding deal, not a standard FAR contract) for a five-year program. The first step is a short Solution Summary due 30 Nov 2026; this is a large, complex, multi-organization effort led by a clinical trial platform operator.
Watch out for
- Very large, multi-party clinical program. Teams need a clinical trial platform operator, FDA-regulated IND holder, drug sponsors, statisticians, AI modelers and six or more trial sites, which is beyond most small businesses acting alone.
Each platform must include at least six clinical sites by the end of the program.
- Must sustain the platform for about a decade after funding. Proposers must show a deep pipeline of sponsors and a long-term plan, and the prime must be able to sustain the platform after the program ends.
sponsor demand, to sustain continued platform use for approximately a decade after SURPASS
- Hard FDA go/no-go gate. Continuing into Stage II depends on FDA authorization to proceed for the platform IND and at least one arm by the end of Stage I.
FDA authorization to proceed for the platform Master Protocol IND, as well as the same
- Ambitious performance metrics. Metrics include cutting sample sizes by 33 to 50 percent, IRB approval in under a week and replacing most control participants with in silico methods, which carry real technical risk.
- Cost sharing strongly encouraged and costs not reimbursed. ARPA-H will not pay for Solution Summary, pitch or Proposers' Day costs, and funding for trial arms is limited to the first three, partially the fourth and fifth.
Cost sharing by Core Platform Teams is strongly encouraged.
- Strict conformance rules and a mandatory pitch. Submissions that ignore the ISO format may be rejected without review, and conforming teams must give a live virtual pitch in early February 2027.
NOTE: Non-conforming submissions that do not follow ISO instructions may be rejected
Read from the notice and 2 attachments. 1 not read in full.
- SOL_26_164_Attach 1_SOW Template.docx
- SOL_26_164_SURPASS ISO.pdf
- SOL_26_164_Attach 2_Cost Workbook.xlsx: spreadsheet: not read yet
Full brief
What they want
- A platform trial in one disease area with a master protocol, shared controls and a seamless Phase 1 to efficacy design (at least three drug or biologic arms)
- Technical Area 1: a simulation-based design engine plus in silico models such as digital twins
- Technical Area 2: continuous statistical inference and adaptation, with an independent statistical analysis committee and a blinding plan
- Technical Area 3: AI-enabled clinical operations (site activation, contracting, IRB, data cleaning, monitoring, safety reporting)
- A multi-site clinical network (at least six sites by program end) with the first site open by program year 2
- A lead platform operator, governance model and a plan to sustain the platform for about 10 years after ARPA-H funding
- At least two for-profit drug or biologic sponsors per team, including one startup or small company
- Engagement with FDA, including authorization to proceed on the master protocol IND by the end of Stage I
- Contract type
- Other Transaction (OT) agreements; multiple awards anticipated
- Period of performance
- Five-year program: Stage I (24 months) plus Stage II (36 months)
- Contract vehicle
- ARPA-H Innovative Solutions Opening (ISO); Other Transaction agreements, submitted through the ARPA-H Solutions site
- How they'll choose
- Most advantageous solutions are selected for negotiation; Solution Summaries are screened first, then Solution Pitch packages and a mandatory virtual pitch are evaluated, each on its own merit
- Offers due
- Solution Summary: 30 NOV 2026 by 5pm ET (ISO closing date). Solution Pitch Package (by invitation after feedback): estimated 22 JAN 2027 by 5pm ET. Virtual pitches estimated 1-5 FEB 2027. Questions due 2 NOV 2026.
- How to submit
- Online through the ARPA-H Solutions site (https://solutions.arpa-h.gov/); register in advance. Questions go to SURPASS@ARPA-H.GOV
- Page limits
- Solution Summary: 4 pages (cover page, rough order of magnitude with basis of estimate, and references do not count); 11-point sans-serif font, 1-inch margins. Pitch deck: maximum 21 slides.
What they'll judge offers on
- Innovation
- Feasibility
- Scientific and technical merit in the context of the program requirements
What to include when you submit
- Solution Summary must follow Appendix B: cover page, proposed work (disease area, arms, sponsors, TA1-TA3, regulatory strategy, sustainability, why your solution is better) and a rough order of magnitude budget
- Solution Pitch package (if invited) includes a pitch deck, Excel Gantt chart, preliminary master protocol, 2-page in silico and AI model description, Scope of Work (Word template) and Cost Workbook (Excel template)
- Optional PDF appendix of regulatory documents already shared with regulators
- Mark proprietary information with a label such as Proprietary on the cover page and each affected page
- Include an organizational conflict of interest disclosure (does not count toward the page limit) and affirm whether you provide professional support services to ARPA-H
- Attend a mandatory 15-minute virtual pitch with up to 45 minutes of government questions if your pitch package is conforming
- Optional: informational webinar 15 OCT 2026 and Proposers' Day 6 and 9 NOV 2026 (not required)
You must have
- SAM.gov registration started with a Unique Entity ID to be conforming, and active registration to receive an award
have an active registration in SAM to be eligible for an Award with ARPA-H.
- FFRDCs and government entities (including federal employees) cannot be a prime or sub-performer
not permitted to respond to this solicitation as a prime or sub- Performer on a
- No awards to entities organized under the laws of a covered foreign country, or to suspended or debarred entities
made to entities organized under the laws of a covered foreign country (as defined in
- Each Core Platform Team must work across all three Technical Areas and include experts in project management, biostatistics, regulatory affairs, clinical medicine, AI modeling and clinical operations, plus drug or biologic sponsors
Each Core Platform Team must propose to and perform work across all three Technical
- At least three drug or biologic intervention arms, and at least two for-profit drug or biologic sponsors including one startup or small company
Each Core Platform Team must propose at least three drug or biologic intervention arms.
- Organizational conflict of interest disclosure is required; a current ARPA-H professional support services role cannot be mitigated and makes you ineligible
Note: An OCI based on a Proposer currently providing professional support services,
- Human subjects research needs a Federal Wide Assurance, IRB approval and training documentation
Funding cannot be used toward human subjects research until ALL approvals are granted.
Not in the notice text
- Total program funding or expected award size (not stated in the ISO)
- Detailed budget template contents: the Cost Workbook spreadsheet was not read
- Exact final dates for the Solution Pitch Package and pitches (estimates only until feedback letters)
- Place of performance (left open; proposers choose sites)
- Award terms and conditions, which are negotiated after selection
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Key facts
- Response due
- Nov 30, 2026, 10:00 PM UTC
- Posted
- Sep 30, 2026
- Notice type
- Solicitation
- Solicitation
- ARPA-H-SOL-26-164
- Agency
- Department of Health and Human Services · National Institutes of Health
- Office
- Advanced Research Projects Agency for Health (Arpa-H)
- NAICS
- 541714
- Product/service code
- AN13
- Business type
- Engineering, architecture & research
- Contracting contact
- The SURPASS TeamSURPASS@ARPA-H.GOV
What similar contracts paid
8 contracts at this agency for the same NAICS and product/service codes had activity in the last 5 years, according to USAspending.gov. Small businesses won 31% of the dollars in this market over the last 3 fiscal years.
Typical contract$2MMiddle half: $2M to $2M
Typical per year$796KValue divided by years of performance
Before you respond
Full notice text from SAM.gov
The Advanced Research Projects Agency for Health (ARPA-H) posts this solicitation in support of its Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) Program. ARPA-H anticipates multiple Other Transaction Agreement awards will result from this opportunity. Interested parties are invited to review the attached Solicitation (ARPA-H-SOL-26-164) and associated attachments. As detailed in Special Notice ARPA-H-SN-26-164, ARPA-H will host an informational webinar on 15 OCT 2026 and a 2-day Proposers’ Day on 6 and 9 NOV 2026 in support of SURPASS. All questions related to SURPASS should be submitted to SURPASS@ARPA-H.GOV.
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