Sterling IRB
Sterling IRB is a private, AAHRPP-accredited independent Institutional Review Board based in Atlanta that provides IRB review, informed consent preparation, certified translation, and decentralized trial services to biopharma, CROs, academic institutions, hospitals, and federal agencies across the U.S. and Canada.
- Company typePrivate
- Founded1995
- HeadquartersAtlanta, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Sterling IRB does
Sterling Institutional Review Board is a private, independent Institutional Review Board company headquartered in Atlanta, Georgia, operating for over 30 years as a dedicated provider of IRB services to the clinical research industry. The company serves biopharmaceutical and medical device companies, contract research organizations (CROs), federal agencies, academic research institutions, hospitals, and individual investigators conducting Phase I through Phase IV clinical trials across all therapeutic areas in the U.S. and Canada. Sterling IRB holds full AAHRPP accreditation (since 2010), OHRP/FDA IRB registration (IRB00001790), Federalwide Assurance FWA00035922, SMART IRB participating institution status, and a Health Canada REB attestation.
The core technology platform is SilverLink, a proprietary secure web portal that enables paperless electronic IRB submission, xForms smart forms, study tracking, and document management across the entire submission lifecycle. Sterling delivers IRB review services through a dedicated account-management model in which each study sponsor is assigned a Certified IRB Professional (CIP)-certified account manager for the duration of the study. Operational commitments include daily board meetings Monday through Friday, a 5-business-day protocol review turnaround, 24-hour site review turnaround, 2-business-day expedited review, and 24/7 expert support, backed by a North American Panel that convenes Fridays for cross-border U.S.-Canada multicenter trial oversight.
The revenue model combines a subscription-style IRB review fee schedule (new study submissions, amendments, site reviews, continuing reviews) with professional-services revenue from informed consent document preparation (including eConsent for decentralized trials) and certified translation services. Sterling uses an enterprise field-sales go-to-market motion serving institutional buyers, with all submissions processed through the SilverLink portal and no disclosed channel partners or resellers. The company maintains compliance with 45 CFR Part 46, 21 CFR Parts 50 and 56, ICH GCP, HIPAA, GDPR, and CCPA, and is veteran-owned (NVBDC member). Sterling has no disclosed parent company, no external funding rounds, and no M&A activity recorded in the available data.
Sterling IRB firmographics
Firmographics- Name
- Sterling IRB
- Legal name
- Sterling Institutional Review Board
- Website
- https://sterlingirb.com
- Company type
- Private
- Founded year
- 1995
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Sterling IRB is a private, AAHRPP-accredited independent Institutional Review Board based in Atlanta that provides IRB review, informed consent preparation, certified translation, and decentralized trial services to biopharma, CROs, academic institutions, hospitals, and federal agencies across the U.S. and Canada.
- Ownership category
- akta.pro rank
Sterling IRB industry classification
Industry- Product category
- Institutional Review Board Services
- NAICS
- Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical Research Ethics & Human Subjects Protection Authorities (IRB/REC Oversight) (HLAJACAG)
- akta.pro secondary industry
- Research Administration & Compliance (Sponsored Programs, IRB/REB) (EDADAKAH)
Keywords
Where Sterling IRB is headquartered
LocationHeadquarters
- HQ city
- Atlanta
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Sterling IRB business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- IRB Review Services: Sterling IRB generates revenue through fees for IRB review services, including new study submissions, protocol amendments, site reviews, continuing reviews, and other IRB-related services. Fee schedules are provided upon request and vary by submission type and study complexity.
- Informed Consent Document Preparation: Specialized informed consent and parental permission/assent document preparation services, including eConsent solutions for decentralized trials.
- Certified Translation Services: Certified translation services for all documents related to the initial and continuing review of research, including informed consent documents, participant handouts, and recruitment materials.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Custom fee schedule based on study type and submission category |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels8 records
Sterling IRB product offering
Product offeringCore offering
Sterling IRB provides dedicated Institutional Review Board (IRB) services for clinical research, including central and local IRB review, full board and expedited reviews, informed consent document preparation (including eConsent), certified translation services, and decentralized clinical trial support. The company delivers these services through its proprietary SilverLink secure web portal, which supports paperless submissions, document management, and study tracking for sponsors, CROs, investigators, and academic institutions across the U.S. and Canada.
Product overview
Sterling IRB is a dedicated Institutional Review Board provider offering a portfolio of interconnected services centered on human subjects research protection and regulatory compliance. The core offering is the SilverLink Web Portal, a secure paperless environment for managing IRB submissions and approvals. This platform serves as the hub through which all Sterling IRB services are delivered, including full board and expedited IRB review services, informed consent document preparation (including eConsent for decentralized trials), certified translation services, decentralized clinical trial support, regulatory consulting, and training/education programs. Review services span the U.S. and Canada via a dedicated North American Panel, with specialized institutional solutions for academic medical centers and hospitals requiring single IRB (sIRB) oversight.
Differentiator
Problem solved
Functional benefit
Brands
- SilverLink: Sterling IRB's secure web portal for electronic IRB submissions and document management.
Products and services
- SilverLink Web Portal Sterling IRB's custom secure web portal enabling paperless IRB submissions, study tracking, electronic smart forms (xForms) for new studies, amendments, and continuing reviews, and document management for sponsors, CROs, and investigators.
- IRB Review Services Comprehensive institutional review board services including central and local IRB review, full board and expedited reviews, pre-review protocol consultations including FDA Policy Analyst consultations, and review across U.S. and Canada via the North American Panel.
- Informed Consent Document Preparation Specialized preparation of informed consent and parental permission/assent documents for clinical research, including electronic informed consent (eConsent) solutions designed for decentralized and hybrid clinical trials.
- Certified Translation Services Certified translation services for documents related to the initial and continuing review of research, including informed consent forms, participant handouts, and recruitment materials, managed directly by Sterling IRB's translation team.
- Decentralized Trials Services Expert IRB guidance for fully or partially decentralized clinical trials, including protocol design review for telehealth visits, eConsent, patient apps, home healthcare provider coordination, and mobile technology-enabled data collection.
- Canadian Review Services (North American Panel) IRB review services for clinical trials conducted at research sites across Canada, provided through Sterling IRB's North American Panel which convenes every Friday and operates under a signed Health Canada REB Attestation.
- Institutional IRB Solutions Dedicated IRB solutions for academic research institutions and hospital systems, including single IRB (sIRB) services, SMART IRB reliance agreements, institutional authorization agreements, and custom institutional startup packages.
- Training and Education Human research participant protection training resources for investigators and study staff, including CITI Program modules, GCP training, HIPAA Privacy Rule guidance, Belmont Report training, and FDA/DHHS regulation education.
Quantifiable outcome
- 5 business day protocol review turnaround
- +5 more outcomes
Companies that use Sterling IRB
Customer profileNamed customers6 records
Segments6 records
Ideal customer profiles4 records
Sterling IRB technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Sterling IRB partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- SMART IRBcoreSterling IRB is a SMART IRB participating institution. Organizations may utilize Sterling's FWA number (FWA00035922) when designating Sterling IRB on SMART IRB agreements and Institutional Authorization Agreements. SMART IRB eases single IRB (sIRB) multisite challenges for federally funded and multisite research.
- National Veteran Business Development Council (NVBDC)minorSterling is a proud member of the NVBDC, recognizing the company as a veteran-owned business development council member.
- Association for the Accreditation of Human Research Protection Programs (AAHRPP)coreSince 2010, Sterling IRB has been fully accredited by AAHRPP, signifying compliance with rigorous standards for human research protection programs. AAHRPP accreditation is a mark of quality for IRB services.
- Clinical Trials for AllminorSterling IRB is a participating partner in the Clinical Trials for All initiative, which aims to improve access to and diversity in clinical trials.
- Collaborative Institutional Training Initiative (CITI)coreSterling IRB offers CITI educational resources to participating investigators and their staff for training in human research participant protection. CITI provides online training modules in GCP, HIPAA, Belmont Report, and FDA/DHHS regulations.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Sterling IRB competitors and assessment
Company assessmentDirect peers
- IntegReview IRB: Independent AAHRPP-accredited commercial IRB providing central and single IRB review for pharmaceutical, biotech, and CRO sponsors. IntegReview is a similar-sized peer to Sterling with overlapping service scope including protocol review, informed consent, and continuing reviews.
- Advarra: Independent commercial IRB formed from the combination of Schulman IRB and Quorum Review IRB. Advarra competes directly with Sterling for biopharma, CRO, and academic center IRB work, and is also known for CircleIRB technology and biosafety services.
- BRANY (BioMedical Research Alliance of NY): A national central IRB affiliated with academic medical centers in the Northeast that provides IRB review for industry-sponsored and investigator-initiated studies. BRANY competes with Sterling on multi-site trial review, especially where academic institutions require an academic-aligned IRB.
- WCG (WIRB-Copernicus Group): The largest independent commercial IRB in the U.S., formed from the merger of WIRB and Copernicus Group. WCG is Sterling's closest category competitor, offering central IRB review across all therapeutic areas with significantly broader staffing and enterprise sponsor coverage.
- Chesapeake IRB: AAHRPP-accredited independent IRB providing central IRB services to pharmaceutical, biotech, and academic sponsors. Chesapeake is a smaller-scale direct competitor with a comparable independent commercial IRB operating model.
- Aspire IRB: Independent commercial IRB offering central IRB services to biopharmaceutical and medical device sponsors, with focus on rapid review turnaround and customer service. Aspire is closely comparable in scale and positioning to Sterling, often competing head-to-head for similar sponsor budgets.
Broad incumbents
- Quorum Review IRB (now part of Advarra): Former independent commercial IRB that merged into Advarra. Quorum was historically a near-direct comparable to Sterling with central IRB services and consulted on IRB process best practices, and is retained here as a reference point for the consolidated incumbent competitive set Sterling faces today.
Others
- SMART IRB: Not-for-profit platform that streamlines single IRB reliance agreements across U.S. institutions. Sterling is itself a SMART IRB participating institution, so SMART IRB is an enabler/ecosystem partner rather than a competitor.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Sterling IRB compliance and trust
Trust signalCompliance11 records
Sterling IRB financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sterling IRB leadership team
Management profileNumber of profiles
Profiles8 records
Sterling IRB funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sterling IRB M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Sterling IRB
What does Sterling IRB do?
Sterling IRB provides dedicated Institutional Review Board (IRB) services for clinical research, including central and local IRB review, full board and expedited reviews, informed consent document preparation (including eConsent), certified translation services, and decentralized clinical trial support. The company delivers these services through its proprietary SilverLink secure web portal, which supports paperless submissions, document management, and study tracking for sponsors, CROs, investigators, and academic institutions across the U.S. and Canada.
Is Sterling IRB a public or private company?
Sterling IRB is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Sterling IRB founded?
Sterling IRB was founded in 1995. It employs 11 to 50 people.
Where is Sterling IRB based?
Sterling IRB is headquartered in Atlanta, United States, in the North America region.
How does Sterling IRB make money?
Three revenue lines are on record. IRB Review Services are the primary driver. The others are informed Consent Document Preparation and certified Translation Services.
Who are Sterling IRB's main competitors?
Direct peers on record are IntegReview IRB, Advarra, BRANY (BioMedical Research Alliance of NY), WCG (WIRB-Copernicus Group), Chesapeake IRB and Aspire IRB. Quorum Review IRB (now part of Advarra) is listed as a broad incumbent. SMART IRB is listed as an others.
Does Sterling IRB have an API?
No public API is recorded for Sterling IRB.
What industry is Sterling IRB in?
Sterling IRB's product category is Institutional Review Board Services. Its primary akta.pro industry code is HLAJACAG, Clinical Research Ethics & Human Subjects Protection Authorities (IRB/REC Oversight), with a secondary code of EDADAKAH, Research Administration & Compliance (Sponsored Programs, IRB/REB). Its NAICS code is 541690 and its SIC code is 8731.