Univo IRB
Univo IRB provides independent central ethics review and oversight for clinical research, serving pharmaceutical sponsors, CROs, academic medical centers, research sites, and individual investigators via its proprietary AI-enabled OneVerse platform.
- Company typePrivate
- Founded2016
- HeadquartersRaleigh, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Univo IRB does
Univo IRB is a U.S.-based central Institutional Review Board (IRB) provider offering independent ethics review and oversight for clinical research studies spanning Phase I-IV biomedical, biotech, medical device, and noninterventional trials. Founded in 2016 as Principal IRB, rebranded in February 2024, and acquired by healthcare-focused private equity firm QHP Capital in 2023, the company is headquartered in Raleigh, North Carolina, and operates primarily across North America, having launched Canadian Research Ethics Board (REB) review services in September 2024. Univo sells centralized study review services to sponsors, contract research organizations (CROs), academic medical centers, hospitals, research sites, and individual investigators under a quote-based professional-services model with multi-year contract support.
The company's core product is OneVerse®, a proprietary purpose-built electronic IRB submission portal that combines electronic submissions, real-time status tracking, dynamic form generation, document collaboration, and—since September 2025—AI-powered workflow automation covering process automation, predictive review-timeline forecasting, and knowledge retrieval. Adjacent revenue streams include Institutional Biosafety Committee (IBC) services, Human Research Protection (HRP) and Good Clinical Practice (GCP) training, and clinical research consulting on AI governance, auditing, study design, and voice-of-patient services. Pricing is not publicly disclosed; customers engage Univo through dedicated IRB professionals supplemented by the OneVerse self-serve portal and direct sales motion.
Univo differentiates through AAHRPP accreditation (held since 2020, reaccredited for five years in September 2023), FDA registration (IORG0009156 / IRB00010912) with a January 2026 inspection completed with zero findings, a leadership team composed of veterans from Independent IRB, Schulman, and Advarra, and strategic alliances with Validcare (June 2026, integrated CRO+IRB platform for emerging biotech) and The Patient View (January 2026, patient-insight analytics). Distribution relies on direct enterprise sales, industry-conference presence (SCOPE, ADLM, PRIM&R, ClinOps at Sea, SCRS Global), and a content-and-podcast-driven thought-leadership channel.
Univo IRB firmographics
Firmographics- Name
- Univo IRB
- Legal name
- Univo LLC
- Website
- https://univo-group.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Univo IRB provides independent central ethics review and oversight for clinical research, serving pharmaceutical sponsors, CROs, academic medical centers, research sites, and individual investigators via its proprietary AI-enabled OneVerse platform.
- Ownership category
- akta.pro rank
Univo IRB industry classification
Industry- Product category
- Institutional Review Board Services
- NAICS
- Other Scientific and Technical Consulting Services (54169), Educational Support Services (611710)
- SIC
- Services-Misc Health & Allied Services, Nec (8090)
- 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 Univo IRB is headquartered
LocationHeadquarters
- HQ city
- Raleigh
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Univo 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: Core revenue from providing independent ethics review and oversight for clinical research including Phase I-IV biomedical, biotech, medical device, and noninterventional studies. Revenue is generated through study review fees, with dedicated professionals assigned to each client.
- Institutional Biosafety Committee (IBC) Services: Support services for institutional biosafety committee approval as part of comprehensive regulatory oversight.
- Training Services: Human research protection (HRP) and good clinical practice (GCP) training services for research teams, administrators, and compliance staff. Includes accredited and certified training modules.
- Clinical Research Consulting: Consulting services including strategic guidance for research administration, AI governance, auditing and compliance, research study design, temporary staffing solutions, and voice of patient services.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Quote-based pricing - contact for fee schedule |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
Univo IRB product offering
Product offeringCore offering
Univo IRB provides independent Institutional Review Board (IRB) ethics review and oversight services for clinical research, covering Phase I-IV biomedical, biotech, medical device, and noninterventional studies. Core service delivery is supported by OneVerse®, a proprietary AI-enabled electronic IRB submission and workflow platform. Surrounding the platform, Univo IRB offers Institutional Biosafety Committee (IBC) approval support, Human Research Protection (HRP) and Good Clinical Practice (GCP) training, and clinical research consulting including AI governance, auditing, staffing, and patient insight services.
Product overview
Univo IRB operates as a next-generation Institutional Review Board provider offering a unified portfolio centered on its proprietary OneVerse® technology platform. OneVerse serves as the core electronic IRB platform enabling AI-powered workflow automation, electronic submissions, and real-time collaboration. Surrounding this platform, Univo provides complementary service modules including IRB Review Services (Phase I-IV biomedical, device, and behavioral research), IBC Services for biosafety committee approval, Training Services (HRP/GCP certification), and Clinical Research Consulting Services (strategic guidance, AI governance, auditing, and voice-of-patient support). The company emphasizes an integrated approach where technology and human expertise combine to deliver agile, patient-centered ethics review.
Differentiator
Problem solved
Functional benefit
Brands
- OneVerse: AI-enabled, purpose-built electronic IRB submission portal and platform for central IRB review, enabling study submission, secure document sharing, and direct communication across research study stakeholders.
Products and services
- OneVerse® Platform Proprietary purpose-built electronic IRB platform that modernizes IRB submission, review, and oversight. OneVerse provides AI-powered workflow automation, dynamic form generation, searchable submission tracking, live chat support, 24/7 access to resources and guidance, auto-population of data, and real-time collaboration tools for study teams, IRB members, and sponsors/CROs.
- IRB Review Services Independent ethics review and oversight for clinical research ensuring participant protection and regulatory compliance. Covers Phase I-IV biomedical, biotech, medical device, and noninterventional studies, with full board, expedited, and exempt determinations.
- IBC Services
Quantifiable outcome
- Up to 60% reduction in average turnaround times reported by early adopters
- +4 more outcomes
Companies that use Univo IRB
Customer profileNamed customers6 records
Segments4 records
Ideal customer profiles4 records
Univo IRB technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature2 records
Univo IRB partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- ValidcarecoreStrategic alliance designed to provide emerging biotech and biopharma sponsors with a modernized, end-to-end experience that makes Real-Time Clinical Trials (RTCTs) a reality. The partnership integrates Univo IRB's efficient IRB model with Validcare's cloud-based SmartSource Clinical Study Platform, providing real-time visibility to high-integrity data via one cloud-based platform. This unified ecosystem connects sponsors, clinical operations, sites, patients, and regulators, accelerating study timelines and reducing costs. Validcare COO Rodney Nuss cited Univo IRB's easy-to-use web-based tools, clear turnaround times, and instant access to dedicated experienced resources.
- The Patient ViewcorePartnership to provide essential patient insights that improve clinical trial participation and retention for sponsors and CROs. The collaboration reflects shared belief that patient perspectives should meaningfully inform how clinical research is planned and conducted. The Patient View leads the design and execution of patient insight research using proprietary methodology Walk the Protocol℠ and complementary qualitative approaches. Univo IRB supports coordination and delivery of insights and ethical/regulatory considerations, helping translate patient experience into decision-ready guidance.
Scale indicators6 records
Recent moves10 records
Expansion highlights6 records
Univo IRB competitors and assessment
Company assessmentDirect peers
- IntegReview IRB: IntegReview IRB is an independent central IRB providing review services for Phase I-IV clinical trials, with experience in pharmaceutical, biotech, and medical device studies. It is a direct competitor to Univo IRB with comparable AAHRPP accreditation and enterprise customer base.
- BRANY: BRANY (Biomedical Research Alliance of New York) is a central IRB serving sponsors, CROs, and academic institutions with IRB review, IBC, and research compliance services. It is a direct competitor to Univo IRB, particularly for studies initiated through academic medical centers and hospital systems.
- Sterling IRB: Sterling IRB is an AAHRPP-accredited central IRB providing independent ethics review for clinical trials across pharmaceutical, biotech, and medical device studies. It is a direct competitor to Univo IRB in the same central IRB service category with similar customer segments.
- Copernicus Group IRB: Copernicus Group IRB (CGIRB) is an AAHRPP-accredited central IRB review provider serving biomedical and behavioral research sponsors. It competes directly with Univo IRB for central IRB mandates across all therapeutic areas and phases.
- Advarra (formerly Schulman IRB): Multiple members of Univo IRB's leadership team previously held senior roles at Schulman IRB, which is now part of Advarra. Schulman is referenced as a direct competitor predecessor entity for institutional IRB review across all phases.
- Advarra: Advarra is the largest central IRB in North America, formed from the merger of Schulman IRB, Chesapeake IRB, and Quorum Review. It directly competes with Univo IRB on multi-site Phase I-IV central IRB review, IBC services, and technology-enabled review workflows, serving the same sponsor, CRO, and academic medical center customers.
- WCG IRB: WCG (formerly Western IRB) is one of the largest central IRBs globally, offering IRB review, IBC services, and a suite of clinical research technologies. It competes directly with Univo IRB for institutional and sponsor central IRB mandates across all phases and study types.
Others
- Validcare: Validcare is a CRO partner and strategic ally of Univo IRB (June 2026 alliance) providing a cloud-based SmartSource Clinical Study Platform. It is a peer only in the broader clinical research enablement ecosystem, collaborating on real-time clinical trials rather than directly competing for IRB review.
Regional players
- Veritas IRB: Veritas IRB is a Canadian-based research ethics board providing central IRB/REB services for clinical research in Canada. It is a regional peer to Univo IRB's Canadian REB service, competing for North American clinical trial review mandates.
Emerging players
- Mayo Clinic IRB (Academic Medical Center IRBs): Large academic medical centers (Mayo Clinic, Johns Hopkins, etc.) operate local IRBs and increasingly act as single IRBs of record for multi-site NIH-funded trials. They are an emerging competitive category for sponsor-initiated research, intersecting with Univo IRB's institutional services segment.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Univo IRB social profiles
Digital presenceUnivo IRB compliance and trust
Trust signalCompliance2 records
Univo IRB financial estimates
Financial estimateRevenue estimate
Valuation estimate
Univo IRB leadership team
Management profileNumber of profiles
Profiles7 records
Univo IRB funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Univo 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 Univo IRB
What does Univo IRB do?
Univo IRB provides independent Institutional Review Board (IRB) ethics review and oversight services for clinical research, covering Phase I-IV biomedical, biotech, medical device, and noninterventional studies. Core service delivery is supported by OneVerse®, a proprietary AI-enabled electronic IRB submission and workflow platform. Surrounding the platform, Univo IRB offers Institutional Biosafety Committee (IBC) approval support, Human Research Protection (HRP) and Good Clinical Practice (GCP) training, and clinical research consulting including AI governance, auditing, staffing, and patient insight services.
Is Univo IRB a public or private company?
Univo IRB is a private company. It is classified as private equity controlled and is currently operating.
When was Univo IRB founded?
Univo IRB was founded in 2016. It employs 1 to 10 people.
Where is Univo IRB based?
Univo IRB is headquartered in Raleigh, United States, in the North America region.
How does Univo IRB make money?
Four revenue lines are on record. IRB Review Services are the primary driver. The others are institutional Biosafety Committee (IBC) Services, training Services and clinical Research Consulting.
Who are Univo IRB's main competitors?
Direct peers on record are IntegReview IRB, BRANY, Sterling IRB, Copernicus Group IRB, Advarra (formerly Schulman IRB), Advarra and WCG IRB. Validcare is listed as an others. Veritas IRB is listed as a regional player. Mayo Clinic IRB (Academic Medical Center IRBs) is listed as an emerging player.
Does Univo IRB have an API?
No public API is recorded for Univo IRB.
What industry is Univo IRB in?
Univo 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 54169 and its SIC code is 8090.