75N98026Q00234
NOI - External Institutional Review Board (IRB) Services for Multi-Site Studies
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > NATIONAL INSTITUTES OF HEALTH > NATIONAL INSTITUTES OF HEALTH OLAO
New
Rejected
Quick analysis
NIH/NHLBI issued a Notice of Intent to award a sole-source contract to Advarra, Inc. for external IRB services to maintain continuity for ongoing IDE/IND multi-site studies (FAR 13.106-1(b)(1)).
Work scope is specialized IRB-of-record services under 45 CFR 46 and 21 CFR 56—outside Trace’s core capabilities and past performance lanes.
Access is effectively closed: directed sole-source to the incumbent (Advarra).
No clear strategic value for Trace; misaligned with target agencies and mission areas. Recommendation: Reject.
Scope summary
- Provide external IRB-of-record services for ongoing multi-site IDE/IND studies.
- Maintain compliance with 45 CFR 46 and 21 CFR 56 for FDA-regulated research.
- Perform initial and continuing reviews, amendments, reportable events, emergency use reviews, and site closeout activities.
- Ensure continuity of oversight for studies currently under review (continuity is a stated rationale).
- Handle sensitive human subjects information securely; remote performance acceptable.
- Submit capability statement with pricing, timelines, business size, and active SAM proof by May 5, 2026.
Dimension scores
Total
- 3/100
Technical Fit
- 1/20
Scope is external Institutional Review Board (IRB) services for FDA-regulated IDE/IND multi-site studies (45 CFR 46; 21 CFR 56). Trace’s core capabilities (SATCOM, CDS, MPE, C5ISR, SE&I, IT O&M) do not include IRB services. (NOI; company_profile).
Past Performance
- 0/20
No evidence Trace has IRB or human-subjects review past performance; existing PP is DoD SATCOM/C5ISR/MPE/SE&I. (company_profile; NOI).
Vehicles / Contract Access
- 1/10
Acquisition is a directed sole source under FAR 13.106-1(b)(1) to Advarra, not a vehicle Trace holds and not full/open. While capability statements are accepted, practical access is minimal. (NOI).
Competitive Position
- 0/15
Incumbent/vendor is explicitly named (Advarra). Government cites continuity need for current studies already under Advarra review—clear incumbent advantage and effective exclusion of others. (NOI).
Risk
- 1/15
Very high risk: specialized regulatory service (IRB-of-record) outside Trace’s lanes; sole-source posture; likely accreditation/registration expectations; short timeline. (NOI).
Strategic Value
- 0/10
Does not align with Trace target agencies/missions; does not advance core lanes (SATCOM/CDS/JADC2/etc.). NIH IRB services offer little strategic synergy. (company_profile; NOI).
Compliance
- 0/10
Requirement to serve as IRB of record under 45 CFR 46 and 21 CFR 56; Trace lacks stated IRB credentials/capabilities. Likely non-compliant. (NOI; company_profile).
Concerns
- Directed sole-source to Advarra minimizes competitive access.
- Capability mismatch—IRB accreditation/experience likely required; Trace does not provide IRB services.
- Regulatory non-compliance risk if attempting to prime without qualified IRB partner.
- Short response window for any capability statement with low probability of overturning sole-source posture.
Teaming opportunities
- Accredited external IRB organization capable of serving as IRB of record for IDE/IND multi-site studies.
- Human subjects protection regulatory expertise (45 CFR 46; 21 CFR 56) and established eIRB platform/workflows.
- Experienced staff for timely reviews (initial/continuing, amendments, reportables) and study closeout.
Competitive position
- Not applicable—sole-source to incumbent and outside Trace core capabilities.
Bid/No bid factors
- Notice of Intent to Sole Source naming Advarra, Inc. as the intended awardee.
- Work is outside Trace’s core capabilities and past performance.
- Effective access barrier due to FAR 13.106-1(b)(1) only-one-responsible-source justification.
Documents
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NOI PCA-NHLBI-04883 75N98026Q00234.pdf
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NOI PCA-NHLBI-04883 75N98026Q00234.pdf
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Summary
NIH/NHLBI pre-solicitation Notice of Intent to sole source a contract (75N98026Q00234) for external IRB services to provide centralized IRB-of-record oversight for ongoing multi-site IDE/IND clinical studies; responses due May 5, 2026. The notice cites continuity risks if a new IRB is substituted, identifies Advarra, Inc. as the intended sole source, and defines a one-year period of performance (June 1, 2026–May 31, 2027) with remote performance.
- Agency: HHS > NIH > NHLBI (Division of Intramural Research)
- Solicitation/Notice: 75N98026Q00234; Notice of Intent to Sole Source
- Title: External Institutional Review Board (IRB) Services for Multi-Site Studies
- Response/Due date: May 5, 2026, 9:00 AM EDT; POC: Nicholas Capobianco (nicholas.capobianco@nih.gov)
- NAICS: 541990 (All Other Professional, Scientific, and Technical Services); Size standard $19.5M; Not set aside
- FAR authority: FAR Part 12/13 acquisition; statutory authority FAR 13.106-1(b)(1) (Only One Responsible Source)
- Government intends to award sole source to Advarra, Inc. (Columbia, MD) — justification: need continuity of IRB oversight for studies currently under Advarra review
- Scope: IRB services as-needed including initial/continuing review, investigator reviews, ICF and recruitment material reviews, amendments, reportable events, emergency use reviews, and site closeout
- Technical/regulatory requirements: Must be able to serve as IRB of record for FDA-regulated IDE/IND multi-site studies and comply with 45 CFR 46 and 21 CFR 56
- Place of performance: Remote via electronic communication; POP: 2026-06-01 to 2027-05-31
- Security/handling: Requires secure handling of sensitive human subjects research information
- Solicitation posture: Not a request for competitive proposals, but will accept capability statements; responses must include pricing, timelines, business size, and active SAM proof
Technical details
Entry: sync
Review status: Up to date
Logical upstream opportunity: 46138
Notice lineage:
- 6eae983bc9594902bcc514b2fc60ecaa (posted 2026-04-21) - current
Last synced: 2026-04-21T18:43:44.047626+00:00
Last analyzed: 2026-04-21T18:44:37.163113+00:00
Latest package fingerprint: 34935427e53bac161fbc5c9eb884f9e3909b68a0e0b7f969f4a4045c1081b22b
Latest package notice: 6eae983bc9594902bcc514b2fc60ecaa
Latest package documents: 1
Recent package history- 2026-04-21T18:43:44.049300+00:00: 6eae983bc9594902bcc514b2fc60ecaa with 1 docs
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