Xogene
Xogene provides AI-powered clinical trial transparency and disclosure solutions to biopharma sponsors, offering an integrated platform for global regulatory compliance across 50+ country registries, serving 45+ enterprise pharmaceutical and biotechnology clients.
- Company typePrivate
- Founded2010
- HeadquartersEnglewood, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What Xogene does
Xogene is a privately held clinical trial transparency company founded in 2010 and headquartered in Englewood, New Jersey. It provides transparency outsourcing, management consulting, and technology-driven solutions to biopharma sponsors requiring regulatory disclosure compliance across global clinical trial registries. The company serves 45+ biopharma clients including Top 5, Top 10, and Top 25 biopharmaceutical enterprises, with operations across the US, EU, and India via a best-shore delivery model.
Xogene's core offering is the Transparency Cloud — an integrated portfolio of six products: Prime (end-to-end transparency management platform), Transcend (agentic AI disclosure automation), Determinator (AI-powered redaction/anonymization), GCP (Global Compliance Portal, co-developed with PHUSE), RadarX (ClinicalTrials.gov compliance dashboard), and Reach (patient-facing trial engagement). The technology stack is anchored on an agentic AI architecture where networks of specialized AI agents, equipped with domain-specific regulatory expertise and task-specific guides, process clinical documents (protocols, CSRs, SAPs, statistical tables) and produce registry-ready outputs with claimed 80% time savings. Transcend alone executes 650+ agent-to-agent interactions to verify each output.
The business model combines subscription-based SaaS platform licensing (annual billing, quote-based enterprise pricing) with significant professional services revenue across four streams: clinical trial transparency and disclosure, medical writing and plain language summaries, advisory/consulting, and redaction/anonymization. The company goes to market through direct enterprise field sales initiated via demo requests, supported by industry conference presence (CDD, PHUSE, proprietary US and EU summits), content marketing, and regulatory thought leadership. No funding rounds are publicly disclosed, suggesting the company is bootstrapped or backed by undisclosed private capital.
Xogene firmographics
Firmographics- Name
- Xogene
- Legal name
- Xogene Services LLC
- Website
- https://xogene.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Xogene provides AI-powered clinical trial transparency and disclosure solutions to biopharma sponsors, offering an integrated platform for global regulatory compliance across 50+ country registries, serving 45+ enterprise pharmaceutical and biotechnology clients.
- Ownership category
- akta.pro rank
Xogene industry classification
Industry- Product category
- Clinical Trial Transparency Software
- NAICS
- Software Publishers (5132)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- De-identification, Tokenization & Privacy-Preserving Data Platforms (HLACAIAK)
- akta.pro secondary industries
- Audit, Explainability & Accountability Tooling (traceability, reporting) (HDAAAKAL), Human Oversight, Review & Content Moderation Tooling (HDAAAMAH)
Keywords
Where Xogene is headquartered
LocationHeadquarters
- HQ city
- Englewood
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Xogene business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- SaaS Platform Subscriptions: Subscription-based access to AI-powered transparency platforms (Prime, Transcend, Reach, GCP, RadarX, Determinator) with enterprise licensing typically including implementation, training, and ongoing support
- Clinical Trial Transparency Services: Professional services for end-to-end disclosure support including protocol registration, results posting, EU CTIS submissions, and regulatory compliance consulting
- Redaction and Anonymization Services: Document redaction and anonymization services supporting EMA Policy 0070, Health Canada PRCI, and country-specific registry requirements using Determinator technology
- Advisory Services: Strategic consulting including regulatory intelligence, benchmarking exercises, process assessment, training development, and technology integration support
- Medical Writing Services: Plain language summaries, regulatory clinical writing, protocol development, and clinical study report preparation powered by AI-assisted document generation
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Enterprise platform licensing with customized pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels6 records
Xogene product offering
Product offeringCore offering
Xogene provides AI-powered clinical trial transparency and disclosure solutions for biopharma sponsors. Its Transparency Cloud portfolio includes end-to-end platforms for disclosure management (Prime), disclosure automation via agentic AI (Transcend), anonymization (Determinator), patient engagement (Reach), compliance intelligence (GCP), and analytics (RadarX). These products are complemented by professional services covering registration, results posting, plain language summaries, advisory, and redaction for 50+ global registries.
Product overview
Xogene offers a comprehensive suite of AI-powered clinical trial transparency solutions organized as a platform-plus-products architecture. The Transparency Cloud portfolio includes Prime (the end-to-end transparency management platform), Reach (patient engagement), GCP (global compliance portal with regulatory intelligence), RadarX (ClinicalTrials.gov analytics dashboard), Transcend (AI-powered disclosure automation using agentic AI), and Determinator (automated redaction and anonymization). These products are complemented by professional services covering clinical trial transparency and disclosure, medical writing and plain language summaries, advisory services, and redaction and anonymization. The architecture enables integration across the full transparency lifecycle from registration through results posting, with AI-driven automation delivering up to 80% time savings on routine tasks.
Differentiator
Problem solved
Functional benefit
Brands
- Prime: The industry's first end-to-end transparency platform that streamlines disclosure workflows with AI-powered engine consolidates data and automates complex processes.
- Reach
- GCP
- RadarX
- Transcend
- Determinator
Products and services
- Prime The industry's first end-to-end transparency platform that streamlines disclosure workflows. The AI-powered engine consolidates data from CTMS, spreadsheets, and SAS sources, automates complex processes, and provides unified oversight of all transparency activities across the disclosure lifecycle for biopharma sponsors.
- Reach Patient engagement platform that helps patients and caregivers discover and track relevant clinical trials. Features an AI-powered chatbot for trial discovery and eligibility verification, multilingual support, and patient-friendly content management tools.
- GCP (Global Compliance Portal) Centralized hub for tracking global clinical trial disclosure requirements, developed in collaboration with the PHUSE Data Transparency Working Group. Provides access to mandates across 50+ countries and their registries, with curated regulatory intelligence and email alerts.
- RadarX Compliance dashboard that converts data from ClinicalTrials.gov into user-friendly dashboards for actionable insights on disclosure activities and compliance forecasting. Provides complimentary access to compliance metrics.
- Transcend AI-powered disclosure automation platform using networks of specialized AI agents to extract, draft, refine, assess, and translate clinical trial documents. Handles complex multi-arm study designs and multiple source documents (protocols, CSRs, SAPs, statistical tables) while preserving established processes and delivering up to 80% time savings.
- Determinator AI-powered tool for automating anonymization and redaction. Transforms sensitive regulatory documentation into compliant, submission-ready documents using machine learning technology with built-in QC processes and risk assessment for Protected Personal Information (PPI).
- Clinical Trial Transparency and Disclosure Services End-to-end expert support from protocol registration to results posting. Includes global registration and reporting to ClinicalTrials.gov, EU CTIS, EudraCT, and local registries; comprehensive record management; cross-registry harmonization; and EU CTIS submission support for biopharma sponsors.
- Medical Writing and Plain Language Summary Services Expert services for crafting clear, concise plain language documents and regulatory/clinical writing. Includes template development, plain language summaries of protocol synopsis and results, regulatory writing (protocols, CSRs, IBs), and translation into 200+ languages.
- Advisory Services Expert-led strategy and process optimization including management consulting, benchmarking exercises, process assessment and optimization, training development, technology integration, regulatory intelligence, and global alerts and analysis.
- Redaction and Anonymization Services Full-service redaction and anonymization including support for all redaction types (EU CTIS, journal publications, country-specific registries), EMA Policy 0070 and Health Canada PRCI packages, regulatory agency support, risk assessment, PPI protection, and US Final Rule compliance.
Quantifiable outcome
- Up to 80% time savings on protocol registrations, results postings, plain language summaries, and plain language protocol synopses
- +5 more outcomes
Companies that use Xogene
Customer profileNamed customers6 records
Segments2 records
Ideal customer profiles1 record
Xogene technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability9 records
Feature6 records
Xogene partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- PHUSE Data Transparency Working GroupcoreGCP (Global Compliance Portal) was developed in collaboration with the PHUSE Data Transparency Working Group, combining industry expertise to create a centralized hub for tracking global clinical trial disclosure requirements across 50+ countries.
Scale indicators10 records
Recent moves6 records
Expansion highlights5 records
Xogene competitors and assessment
Company assessmentMarket position
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Xogene social profiles
Digital presenceXogene compliance and trust
Trust signalCompliance1 record
Xogene financial estimates
Financial estimateRevenue estimate
Valuation estimate
Xogene leadership team
Management profileNumber of profiles
Profiles3 records
Xogene funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Xogene 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 Xogene
What does Xogene do?
Xogene provides AI-powered clinical trial transparency and disclosure solutions for biopharma sponsors. Its Transparency Cloud portfolio includes end-to-end platforms for disclosure management (Prime), disclosure automation via agentic AI (Transcend), anonymization (Determinator), patient engagement (Reach), compliance intelligence (GCP), and analytics (RadarX). These products are complemented by professional services covering registration, results posting, plain language summaries, advisory, and redaction for 50+ global registries.
Is Xogene a public or private company?
Xogene is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Xogene founded?
Xogene was founded in 2010. It employs 51 to 100 people.
Where is Xogene based?
Xogene is headquartered in Englewood, United States, in the North America region.
How does Xogene make money?
Five revenue lines are on record. SaaS Platform Subscriptions are the primary driver. The others are clinical Trial Transparency Services, redaction and Anonymization Services, advisory Services and medical Writing Services.
Does Xogene have an API?
No public API is recorded for Xogene.
What industry is Xogene in?
Xogene's product category is Clinical Trial Transparency Software. Its primary akta.pro industry code is HLACAIAK, De-identification, Tokenization & Privacy-Preserving Data Platforms, with a secondary code of HDAAAKAL, Audit, Explainability & Accountability Tooling (traceability, reporting). Its NAICS code is 5132 and its SIC code is 7372.