About
Sterling IRB is an independent institutional review board headquartered in Atlanta, Georgia that reviews human-subject research across the United States and Canada, serving pharmaceutical and biotechnology companies, CROs, federal agencies, individual investigators, hospitals and academic institutions. It offers central and local IRB review from early phase through Phase IV, informed-consent document preparation, review of research involving vulnerable populations, certified translation services, decentralized-trial support and IND safety report guidance, and states a 5-business-day protocol review and 24-hour site review. Submissions and document retrieval run through SilverLink, its secure web portal.
Deterministic scores · rules-based, not AIiHow these scores are obtained: each one is computed from this profile's listed attributes — capability checkboxes, certifications, capacity figures and coverage — by a fixed formula, recomputed on every page load. Deterministic and rules-based means the score comes from a fixed, transparent formula over listed attributes — the same inputs always produce the same score. It is not AI: there is no model, no learning, and no hidden weighting. Whether a score is relevant to you depends on your specific project: a capability that raises the number may not matter for your work, and a niche strength your project needs may barely move it. Capability scores are a directional starting point, not a verdict. A lower score does not disqualify a company or consultant, and no decision should rest on the score alone — always contact the company directly to confirm the specifics for your project.
Oversight iAdds 6 points for each of the 6 compliance credentials this profile checks (AAHRPP, OHRP, FDA, ICH E6 R3, Helsinki, GCP), capped at 36, plus 3 points per review service listed, capped at 34, plus 2 points per study type covered, capped at 30. Levels: 80+ Comprehensive oversight | 60-79 Broad oversight | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
89Comprehensive oversight
Accreditation iWeights each credential by the rigor it signals: AAHRPP accreditation 35 points, OHRP registration 20, FDA registration 15, ICH E6 R3 alignment 15, Declaration of Helsinki adherence 10, and GCP compliance 5, for a maximum of 100. Levels: 80+ Fully accredited | 60-79 Strongly accredited | 40-59 Registered | below 40 Limited. Whether this dimension matters for you depends on your specific project.
100Fully accredited
Review velocity iStarts from 110 and subtracts 1.8 points per day of average full-board approval time, so faster turnaround scores higher. Reporting an average expedited-review time adds a bonus of 14 minus those days, up to 10 points. Shows 0 with Not reported if no full-board approval time is listed. Levels: 80+ Rapid review | 60-79 Efficient | 40-59 Standard | below 40 Extended. Whether this dimension matters for you depends on your specific project.
0Not reported
Geographic reach iAdds 4 points per country served, capped at 40, plus 6 points per region served, capped at 30, plus 15 points if central IRB services are available, plus 3 points per language supported, capped at 15. Levels: 80+ Global reach | 60-79 Multi-region | 40-59 Regional | below 40 Local. Whether this dimension matters for you depends on your specific project.
31Local
Therapeutic depth iAdds 7 points per therapeutic area listed, capped at 60, then fixed bonuses for specialized experience: cell and gene therapy 12 points, pediatric 10, decentralized trials 10, and medical devices 8. Levels: 80+ Deep expertise | 60-79 Broad expertise | 40-59 Established | below 40 Focused. Whether this dimension matters for you depends on your specific project.
63Broad expertise
Capacity & scale iBuilt from four reported volume metrics: annual protocol volume divided by 40, capped at 45 points, active studies divided by 40, capped at 25, reviewer count divided by 4, capped at 20, and 2 points per monthly full-board meeting, capped at 10. Unreported metrics count as zero. Levels: 80+ Enterprise scale | 60-79 Substantial | 40-59 Established | below 40 Boutique. Whether this dimension matters for you depends on your specific project.
0Boutique
Compliance signals
AAHRPP accreditedOHRP registeredFDA registered (IRB)ICH E6(R3) alignedDeclaration of HelsinkiGCP compliant21 CFR Part 11 systemseConsent supportedElectronic submission portalSingle IRB servicesCentral IRB servicesDecentralized trials
Review services
Protocol reviewInformed consent reviewRecruitment material reviewAmendment reviewContinuing reviewSafety report reviewEmergency reviewExpedited reviewFull board reviewSingle IRBCentral IRB
Therapeutic-area experience
OncologyInfectious diseasesCardiovascularImmunologyNeurology
Regions served