Combined Synopsis/Solicitation
Clinical Research Support and Collaboration for NHGRI Protocols
Department of Health and Human Services · National Institutes of Health
AI summaryThe National Institutes of Health (NIH), for its National Human Genome Research Institute (NHGRI), wants one small business to support clinical research under solicitation 75N98026R00034. This is a single-award indefinite-delivery, indefinite-quantity (IDIQ) contract: the work is ordered later through task orders, with an ordering period of January 1, 2027 to December 31, 2029. The response due date is November 13, 2026, 12:00 PM Eastern, and the work is mostly done at the contractor's site. More in the summary
AI summary Beta
The notice looks incomplete: Part of the parent statement of work (the end of Task Area 4 and the start of the task orders, including Task Order 1 Proteus Syndrome Support) and the middle of the IT Security and Privacy Clauses are attached but only partly read: Att_02 - IDIQ SOW_parent_TOs.pdf and Att_06_IT Security and Privacy Clauses.pdf. Check the attachments on SAM.gov.
The National Institutes of Health (NIH), for its National Human Genome Research Institute (NHGRI), wants one small business to support clinical research under solicitation 75N98026R00034. This is a single-award indefinite-delivery, indefinite-quantity (IDIQ) contract: the work is ordered later through task orders, with an ordering period of January 1, 2027 to December 31, 2029. The response due date is November 13, 2026, 12:00 PM Eastern, and the work is mostly done at the contractor's site.
Who can bid
- Small business: this requirement is set aside for small business under NAICS 541690 (size standard $19 million).
- Be able to staff a full range of services: clinical research monitoring and data management, IND and IDE regulatory support, DSMB support and senior statisticians, ideally with genetics and rare disease experience.
- Complete and sign the Section K representations and certifications and include them in the Business Proposal.
How to submit: Electronic submission through the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov; fax and email proposals are not accepted. What to include is under Full summary below. Check the solicitation's instructions on SAM.gov.
Things to watch (10)
From the version posted Oct 26, 2026.
- Serious: Small business set-aside, single award. Only small businesses can bid, and one company wins the whole contract, so you must be able to cover all four task areas yourself or with partners.
- Serious: Low Confidence on any criterion means exclusion. One weak technical criterion (Personnel, Approach, Experience or Past Performance) can knock out an otherwise low-priced offer.
- Serious: Specialized clinical research experience is scored. Experience is judged on NIH studies and genetics, rare disease, pediatric and gene therapy work, plus FDA regulatory filings, which many small firms lack.
Show all 10Show fewer
- Worth checking: Three task orders must be priced; two are for evaluation only. You must build separate time and materials prices for Task Orders 1, 2 and 3, and only Task Order 1 is awarded with the contract.
- Worth checking: Guaranteed minimum is only $50,000. The Government must order at least $50,000 over the contract, against a $4,000,000 maximum, so most of the work is not guaranteed.
- Worth checking: eCPS account can take up to 3 business days. Proposals go only through eCPS, and creating the account is a step a first-time bidder must finish before submitting.
- Worth checking: Strict page limit; extra pages are removed. The technical proposal is capped at 25 pages and pages over the limit are not evaluated, so content must be tight.
- Worth checking: Information security section and Government systems. A separate Information Security section is required in the technical proposal, and staff will use a Government laptop and Government systems.
- Minor: Task order pricing type stated two ways. The RFQ summary says task orders will be time and materials, while the ordering terms say firm-fixed-price or time and materials; ask the contracting officer how orders will be priced.
- Minor: Questions are due October 29, 2026. Requests for clarification are limited to ten questions, each citing the section, paragraph and page.
Read from the notice and 8 attachments. Show which files.
- NHGRI Clinical Research Support RFQ.pdf (read)
- Att_02 - IDIQ SOW_parent_TOs.pdf (read)
- Att_07 - Electronic Invoicing Instructions for NIH ContractorsVendors.pdf (read)
- Att_03 - Technical Evaluation Criteria.pdf (read)
- Att_05 - Section K - Reps Certs and Other Statements of Offerors.pdf (read)
- Att_06_IT Security and Privacy Clauses.pdf (read)
- Att_01 - PackagingandDeliveryofProposalsUsewithNIHeCPSwebsite.pdf (read)
- Att_04 - Reporting Requirements.pdf (read)
Full summary
What they want
- Task Area 1: protocol monitoring, quality assurance and clinical data management for NHGRI studies (the Clinical Director's monitoring program, audits, training, ClinicalTrials.gov data)
- Task Area 2: regulatory support for Investigational New Drug (IND) and Investigational Device Exemption (IDE) filings to the Food and Drug Administration (FDA), including annual and safety reports
- Task Area 3: administrative support for the NHGRI Data Safety and Monitoring Board (DSMB), including meetings, minutes, and a staff member serving as its Executive Secretary
- Task Area 4: senior-level statistical expertise (sample size, power analysis, stopping rules, analysis and reports)
- Price three sample task orders (Task Order 1 Proteus Syndrome Support is awarded with the contract; Task Orders 2 and 3 are priced for evaluation only)
- Deliver quarterly progress reports and a final technical report that meet Section 508 accessibility rules
- Contract type
- Single-award indefinite-delivery, indefinite-quantity (IDIQ) contract; task orders are time and materials (T&M: paid for hours worked plus materials) per the RFQ, and elsewhere firm-fixed-price (FFP) or T&M
- Period of performance
- Ordering period of three years, January 1, 2027 to December 31, 2029; contract award date January 1, 2027; the Government may extend services up to 6 months under RFO 52.217-8
- Place of performance
- Primarily at the contractor's site, with some travel to NHGRI at the NIH campus in Bethesda, MD (as stated in the RFQ)
- Estimated value
- Ordering minimum $50,000 and maximum $4,000,000 for the contract (the stated minimum and maximum, not a Government estimate)
- How they'll choose
- Best value tradeoff: the Government may pick other than the lowest price or the highest rated technical quote. Non-price factors combined are significantly more important than price. Technical criteria get High, Some or Low Confidence ratings, and Low Confidence on any criterion is excluded.
- Offers due
- November 13, 2026, 12:00 PM Eastern
- How to submit
- Electronic submission through the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov; fax and email proposals are not accepted
- Page limits
- Technical proposal: 25 pages (title page, table of contents, dividers, appendices and resumes do not count; the IT section may be an appendix). Resumes: 5 pages each. Business proposal: no page limit.
What they'll judge offers on
- Personnel: qualifications, experience and availability of proposed staff, including senior statisticians (a Ph.D. in statistics or a related field is preferred)
- Technical and Management Approach: transition-in and transition-out, task order management, staffing, quality control, risk handling, continuity
- Offeror Experience: relevant contract experience supporting NIH studies and genetics, rare disease, pediatric and gene therapy research
- Past Performance: recency and relevance, quality, timeliness and problem resolution, using up to 3 recent contracts and the Contractor Performance Assessment Reporting System (CPARS)
- Price: evaluated separately for fairness and reasonableness, across Task Orders 1, 2 and 3
What to include when you submit
- Send the Technical Proposal and the Business Proposal as two separate, complete searchable PDF files; do not refer from one to the other
- Technical file: a transmittal and cover page with the RFQ number, submission date, quote due date, company name, address, phone, website, and a point of contact
- Technical file: include a separate section titled Information Security
- Technical file: show the proposed personnel, with resumes, and the technical and management approach
- Technical file: describe relevant contract experience, giving for each example the organization supported, project description, contract number, value, period of performance, services and your role, and the task areas covered
- Business file: past performance on no more than 3 of your most recent and relevant contracts, with a customer point of contact and any significant performance problem and fix
- Business file: include the signed Section K representations and certifications (Attachment 5)
- Price quote (Volume II): separate time and materials price for each of Task Orders 1, 2 and 3, with labor categories, estimated hours, hourly rates, totals, travel and materials, and a narrative justifying travel and materials costs
- Price quote: include a schedule of loaded hourly rates for all 3 years of the contract with escalation factors; you are held to these rates
- Price Task Order 1 assuming one contractor staff member travels to NHGRI in Bethesda, MD up to three times per contract year, one business day per visit
- Format: letter size pages, 1-inch margins, no web links, no audio or video files, 11 or 12 point Arial or Times New Roman for the technical approach, pages numbered with the company name and RFQ number in a header or footer
- Name files with the offeror name, solicitation number and type (Technical or Business)
- Optional: send a non-binding notice of whether you intend to quote to the Contracting Officer and Contract Specialist by close of business on October 29, 2026
After award, you must have
- Key personnel named in the award may not be replaced without the Contracting Officer's written consent; notice is due at least 30 days before moving someone. From NHGRI Clinical Research Support RFQ.pdf:
The key personnel specified in this contract are considered to be essential to work…
Not in the notice text
- Part of the parent statement of work (the end of Task Area 4 and the start of the task orders, including Task Order 1 Proteus Syndrome Support) and the middle of the IT Security and Privacy Clauses are attached but only partly read: Att_02 - IDIQ SOW_parent_TOs.pdf and Att_06_IT Security and Privacy Clauses.pdf
- Task Order 1's workload, period of performance and staffing assumptions are in the part of the statement of work that was not read
- Whether any security clearance, background check or facility requirements apply; they may be in the IT security clauses that were only partly read
- The key personnel names and the contracting officer's representative are left to be filled in at award
- Whether an incumbent contractor exists is not stated
Eligibility and how to respond
- Set aside for small businesses: only a business that counts as small under this notice's NAICS code can bid as the prime contractor. More open small business set-asides under NAICS 541690
- How to submit, from the AI summary: Electronic submission through the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov; fax and email proposals are not accepted. Check it in the notice before you send anything.
- Service contracts usually set minimum pay rates (the Service Contract Act). Price the labor with the SCA price calculator.
Notice details
- Posted
- Oct 26, 2026
- Notice type
- Combined Synopsis/Solicitation
- Office
- National Institutes of Health Olao, Bethesda, MD
- Product/service code
- R499 · Support – Professional: Other
- Business type
- Consulting & professional services (FedReady's grouping, from NAICS 541690)
- Attachments
Past awards and competition
Who has won work like this before, the likely incumbent, and what similar contracts paid, from USAspending.gov.
Before you respond
- How to respond to a solicitation (8 steps)
- How to read a government solicitation
- How to price a government contract
- Set-aside contracts explained
Terms on this notice: Solicitation, Set-aside
Full notice text from SAM.gov
The goal of this acquisition is to acquire a contractor that offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including DSMB services; (3) analytical solutions, including bioinformatics, and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be capable of providing these services, as required under the individual task orders, to support NHGRI clinical research protocols and related activities within the scope of this IDIQ contract. The contractor should be capable assigning qualified personnel with experience in clinical trial design and regulatory requirements, especially as relates to studies of rare diseases, genetic conditions, gene therapy (including via AAV9 vectors), and pediatric as well as adult populations, as applicable to individual task orders.