Sitero
- Company typePrivate
- Founded-
- HeadquartersCoral Gables, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
Sitero firmographics
Firmographics- Name
- Sitero
- Legal name
- Sitero
- Website
- https://sitero.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
Sitero industry classification
Industry- Product category
- Clinical Research Organization Services
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417), Custom Computer Programming Services (541511)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Prepackaged Software (7372)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industries
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Clinical Site Start-Up & Activation (Regulatory/Ethics/Contracts) (HLAGACAC), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ)
Keywords
Where Sitero is headquartered
LocationHeadquarters
- HQ city
- Coral Gables
- HQ country
- United States
- HQ region
- North America
Offices7 records
Markets served
Sitero business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Others
Revenue model
- Clinical Services: Full-service clinical operations including clinical operations, site support concierge, data management, biostatistics, medical writing, DSMB, and endpoint adjudication services from early phase through Phase III trials.
- Drug Safety Services: End-to-end pharmacovigilance and drug safety services including case processing, clinical safety, literature search, aggregate safety reports, EU/UK QPPV, and PV quality management.
- Biosafety/IBC Services: Institutional Biosafety Committee services including IBC services, consulting, training, and e-learning solutions.
- Mentor eClinical Technology: SaaS platform providing Mentor EDC, RTSM, CTMS/eTMF, eConsent, and site/participant payment solutions. Pricing typically subscription-based for software access.
- Mentor eCompliance Technology: SaaS compliance platform for IRB, IBC, IACUC, COI, and grants management. Subscription-based licensing model.
- IRB Ethical Review Services: Institutional Review Board services with transparent flat-fee structure for protocol reviews and ethical oversight.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Custom enterprise pricing based on study scope and requirements |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
Sitero product offering
Product offeringCore offering
Sitero is a next-generation clinical research organization (CRO) that delivers full-service clinical operations, drug safety, biosafety/IBC, and IRB ethical review services alongside its proprietary Mentor technology platform. The Mentor platform comprises Mentor eClinical (eConsent, EDC, RTSM, CTMS/eTMF, site and participant payments) for clinical trial execution and Mentor eCompliance (IRB, IBC, IACUC, COI, grants management, education) for research administration. Following the 2025 acquisition of StudyOS, Sitero added SiteroAI, an AI layer built on the Ash AI engine that delivers 20-30% efficiency gains across the clinical development lifecycle.
Product overview
Sitero offers a dual-platform product portfolio combining eClinical technology and eCompliance solutions. The Mentor eClinical platform (including Mentor EDC, Mentor RTSM, Mentor CTMS/eTMF, Mentor eConsent, Mentor Site Payments, Mentor Participant Payments) powers clinical trial operations, while the Mentor eCompliance platform (Mentor IRB, Mentor IBC, Mentor IACUC, Mentor COI, Mentor Grants Management, Mentor Education) serves research and higher education institutions. Additionally, SiteroAI integrates StudyOS's Ash AI technology with the Mentor platform for AI-powered clinical operations. Full-service clinical capabilities include Clinical Services, Drug Safety, Biosafety/IBC, and IRB Ethical Review.
Differentiator
Problem solved
Functional benefit
Brands
- Sitero Mentor: Technology platform for research compliance including IRB, IBC, IACUC, and higher education sectors. Previously known as Axiom Mentor before October 2022 acquisition.
- SiteroAI
- Mentor eClinical
- Mentor eCompliance
Products and services
- Mentor eClinical End-to-end cloud-based eClinical technology platform that supports clinical trial operations for pharmaceutical sponsors, biotech companies, and medical device manufacturers, integrating eConsent, EDC, RTSM, CTMS/eTMF, and site/participant payment modules on AWS.
- Mentor eCompliance Compliance platform for research administration that automates IRB, IBC, IACUC, COI, Grants Management, and Education workflows for universities, hospitals, and research institutions, with SSO via LDAP, Active Directory, CAS, and Shibboleth and ERP integration with Banner, PeopleSoft, and Datatel.
- SiteroAI AI-powered platform built on StudyOS's Ash technology and integrated with the Mentor eClinical suite that delivers 20-30% efficiency gains across the clinical development lifecycle through generative AI, NLP-driven conversational data access, automated medical coding, anomaly detection, and AI-augmented data management for clinical operations.
- Fusion eClinical Suite Unified eClinical platform with 15+ integrated modules spanning EDC, RTSM, CTMS, ePRO, and eTMF acquired through the Axiom Real-Time Metrics transaction and integrated into Sitero's clinical operations.
- Clinical Services Full-service clinical operations offering for pharmaceutical, biotech, and medical device sponsors, covering clinical operations, site support concierge, data management, biostatistics, medical writing, Data & Safety Monitoring Board, and endpoint adjudication from early phase through Phase III trials.
- Drug Safety Services End-to-end drug safety and pharmacovigilance services including case processing, clinical safety, global literature search, aggregate safety report authoring, EU & UK QPPV and Responsible Person services, safety evaluation and risk management, PV quality and compliance management, and SDEAs/PVAs for global sponsors.
- Biosafety / IBC Services Biosafety services for institutions and clinical sites including IBC services, biosafety consulting, biosafety training, IBC resources, and an E-Learning Biosafety Suite to support increasingly complex biosafety regulatory and compliance processes.
- IRB Ethical Review Services Institutional Review Board services for protocol reviews and ethical oversight with a transparent flat-fee structure, delivered by experienced ethicists using a patient-centric approach for sponsors and institutions.
Quantifiable outcome
- 25% faster study startup vs standard industry timeline
- +12 more outcomes
Companies that use Sitero
Customer profileNamed customers11 records
Segments4 records
Ideal customer profiles3 records
Sitero technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration7 records
AI capability9 records
Feature13 records
Sitero partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- CRIOcoreStrategic partnership to lift administrative burden of clinical research for sites and sponsors while improving patient safety, experience and outcomes. The partnership revolutionizes trial execution by removing manual, redundant and error-prone activities. Leverages CRIO's eSource technology platform with Sitero's clinical expertise for next-generation delivery model managing recruitment, patient scheduling, data management, IRB/IBC services, eConsent, eRegulatory/eISF, eSource and patient stipends.
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Sitero competitors and assessment
Company assessmentEmerging players
- CRIO: eSource and eRegulatory platform supporting 2,000+ research sites globally; Sitero's strategic technology partner driving the headline enrollment and deviation metrics. Comparable as a site-focused clinical technology enabler in Sitero's go-to-market ecosystem.
- Advarra: Provider of IRB, IBC, and research compliance technology and services for research institutions and sponsors. Directly comparable to Sitero's Mentor eCompliance platform (IRB, IBC, COI, IACUC) — overlapping technology and service footprint in research administration.
Direct peers
- Celerion: Early-phase clinical research and bioanalytical services CRO with strong scientific depth. Comparable to Sitero's clinical operations focus on complex protocols and biomarker-driven trial design.
- Medpace: Mid-sized, tech-forward full-service CRO with strong sponsor relationships in oncology and specialty therapeutics. Highly comparable to Sitero as a focused, operationally rigorous alternative to mega-CROs.
- Premier Research: Specialty-focused CRO with strong oncology, rare disease, and pediatric capabilities serving biotech and mid-size pharma. Directly comparable to Sitero's therapeutic-area depth and mid-market positioning.
- Worldwide Clinical Trials: Mid-market global CRO offering full-service clinical operations with therapeutic-area depth in oncology, CNS, and rare disease. Closely comparable to Sitero's positioning as a mid-sized, technology-enabled CRO for complex trials.
Broad incumbents
- ICON plc: Top-3 global CRO offering full-service clinical development, labs, and commercialization services post-PRA Health Sciences integration. Represents the scaled incumbent benchmark against which Sitero competes for large pharma mandates.
- IQVIA: Largest global CRO and life sciences technology provider with end-to-end Phase I–IV services, real-world evidence, and proprietary clinical platforms. Sets the competitive ceiling that Sitero's tech-enabled mid-market model must differentiate against.
- Veeva Systems: Cloud software provider for life sciences with clinical, regulatory, and quality suites including CTMS, eTMF, and RTSM. Comparable to the Mentor eClinical platform as competing SaaS infrastructure for clinical trial operations.
- Medidata Solutions (Dassault Systèmes): Leading eClinical platform with Rave EDC, RTSM, eCOA, and CTMS used across pharma R&D. Comparable to Sitero's Mentor eClinical suite as competing clinical trial technology infrastructure with significant sponsor mind-share.
Market position
Strengths2 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Sitero social profiles
Digital presenceSitero compliance and trust
Trust signalCompliance1 record
Sitero financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sitero leadership team
Management profileNumber of profiles
Profiles7 records
Sitero subsidiaries and ownership
Company hierarchySubsidiaries4 records
Sitero funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sitero M&A and investment
M&A and investmentM&A3 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Sitero
What does Sitero do?
Sitero is a next-generation clinical research organization (CRO) that delivers full-service clinical operations, drug safety, biosafety/IBC, and IRB ethical review services alongside its proprietary Mentor technology platform. The Mentor platform comprises Mentor eClinical (eConsent, EDC, RTSM, CTMS/eTMF, site and participant payments) for clinical trial execution and Mentor eCompliance (IRB, IBC, IACUC, COI, grants management, education) for research administration. Following the 2025 acquisition of StudyOS, Sitero added SiteroAI, an AI layer built on the Ash AI engine that delivers 20-30% efficiency gains across the clinical development lifecycle.
Is Sitero a public or private company?
Sitero is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Sitero founded?
Sitero was founded in -1. It employs 11 to 50 people.
Where is Sitero based?
Sitero is headquartered in Coral Gables, United States, in the North America region.
How does Sitero make money?
Six revenue lines are on record. Clinical Services are the primary driver. The others are drug Safety Services, biosafety/IBC Services, mentor eClinical Technology, mentor eCompliance Technology and IRB Ethical Review Services.
Who are Sitero's main competitors?
Emerging players on record are CRIO and Advarra. Direct peers are Celerion, Medpace, Premier Research and Worldwide Clinical Trials. Broad incumbents are ICON plc, IQVIA, Veeva Systems and Medidata Solutions (Dassault Systèmes).
Does Sitero have an API?
No public API is recorded for Sitero.
What industry is Sitero in?
Sitero's product category is Clinical Research Organization Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs. Its NAICS code is 54171 and its SIC code is 8731.