PhaseV
PhaseV provides an AI/ML platform for clinical trial design and operations, serving global biopharma sponsors and CROs. Its modules use causal ML and Bayesian statistics to optimize trial design, identify responder subgroups, model disease biology, and select clinical sites.
- Company typePrivate
- Founded2023
- HeadquartersBoston, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What PhaseV does
PhaseV is a privately held, AI-native clinical development technology company founded in 2023 and headquartered in Cambridge, Massachusetts, with an engineering and R&D office in Tel Aviv, Israel. The company sells an end-to-end AI/ML platform to global biopharma sponsors and contract research organizations, organized as four core modules — Trial Optimizer (Bayesian and adaptive trial design simulation), Response Optimizer (causal ML for heterogeneous treatment effect and responder subgroup detection), Portfolio Optimizer (causal disease modeling for biomarker and indication strategy), and ClinOps Optimizer (causal ML-driven site selection and trial operations) — plus a 10M+ patient-level DataLake, the recently launched AI Conductor protocol-to-submission automation platform (March 2026), and an AI-Powered Enrollment Lab (February 2026).
The platform's underlying technology combines Bayesian statistics, causal machine learning, GenAI, and reinforcement learning, applied across structured clinical trial and real-world patient-level data with proprietary methods such as Causal Responder Detection (CARD), Robust CATE ensemble estimation, ML Early-Derived Endpoint Identification, and Hidden Markov Model-based RWD cleaning. PhaseV is cloud-native on AWS and holds ISO 27001, GDPR, HIPAA, and CCPA certifications.
PhaseV operates a hybrid revenue model combining per-project tech-enabled services (professional services delivered by in-house ML, data science, clinical, and medical experts) with optional recurring SaaS subscriptions to individual platform modules, sold under multi-year enterprise contracts. Distribution runs through direct enterprise sales (Book a Demo CTAs), a growing CRO channel (Quanticate, Bioforum, iOMEDICO, Alimentiv), marketplace listings (9xchange Biopharma), and co-development partnerships with foundations such as the Crohn's & Colitis Foundation. As of late 2025 the company reported 45+ biopharma and CRO customers including at least 7 big pharma, with 2025 revenues described as nearly quintupling year-over-year.
PhaseV firmographics
Firmographics- Name
- PhaseV
- Legal name
- PhaseV
- Website
- https://phasevtrials.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- PhaseV provides an AI/ML platform for clinical trial design and operations, serving global biopharma sponsors and CROs. Its modules use causal ML and Bayesian statistics to optimize trial design, identify responder subgroups, model disease biology, and select clinical sites.
- Ownership category
- akta.pro rank
PhaseV industry classification
Industry- Product category
- Clinical Trial Optimization Software
- NAICS
- Custom Computer Programming Services (541511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Computer Systems Design Services (541512)
- SIC
- Services-Prepackaged Software (7372), Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)
- akta.pro secondary industries
- Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)
Keywords
Where PhaseV is headquartered
LocationHeadquarters
- HQ city
- Boston
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
PhaseV business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations
Revenue model
- Tech-Enabled Services (Professional Services): Project-based engagements where sponsors/CROs contract PhaseV to deliver tech-enabled services. Scope, timelines and cost defined per project with a dedicated team of ML, data-science, clinical and medical experts providing white-glove service throughout the project.
- Software as a Service (SaaS) Subscription: Recurring subscriptions to one or more PhaseV platform modules (Trial Optimizer, Response Optimizer, Portfolio Optimizer, ClinOps Optimizer) for self-serve use, with ongoing troubleshooting support and customization. Cloud-native on AWS and compatible with most EDC systems.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Per-project Tech-Enabled Services with optional subscription layering |
Go-to-market motion3 records
Distribution channels5 records
Marketing channels11 records
PhaseV product offering
Product offeringCore offering
PhaseV provides an AI/ML-driven platform that helps biopharma sponsors and CROs design, optimize, and execute clinical trials more efficiently. The platform combines causal machine learning, Bayesian adaptive design, GenAI, and reinforcement learning on top of a 10M+ patient data lake to support trial simulation, heterogeneous treatment effect analysis, biomarker-driven portfolio decisions, and ML-driven site selection. Offerings are delivered as multi-module SaaS subscriptions (Trial Optimizer, Response Optimizer, Portfolio Optimizer, ClinOps Optimizer, AI Conductor) plus project-based tech-enabled services.
Product overview
PhaseV offers a unified multi-modal AI/ML platform for end-to-end clinical development, structured as a platform-plus-modules architecture that seamlessly bridges retrospective data analysis with trial design and execution. The core platform consists of four primary modules — Trial Optimizer (AI-driven trial design simulation and optimization), Response Optimizer (causal ML for heterogeneous treatment effect detection and subgroup identification), Portfolio Optimizer (causal disease modeling for biomarker analysis and indication selection), and ClinOps Optimizer (causal ML-driven site selection and real-time trial operations analytics). These modules are powered by the PhaseV DataLake, a proprietary data infrastructure containing 10M+ patient-level records, and are augmented by the AI Conductor centralized automation platform, the AI-Powered Enrollment Lab, and ML Early-Derived Endpoint Identification capabilities. Together, these offerings support biopharma sponsors and CROs across the full clinical development lifecycle, including trial design, patient stratification, site selection, asset evaluation, indication sequencing, and regulatory submission.
Differentiator
Problem solved
Functional benefit
Brands
- Trial Optimizer: AI/ML platform module that runs millions of adaptive, Bayesian, and fixed trial design simulations to optimize sample size, cost, and probability of success.
- Response Optimizer
- Portfolio Optimizer
- ClinOps Optimizer
- AI Conductor
- AI-Powered Enrollment Lab
Products and services
- Trial Optimizer AI/ML-powered module that runs millions of adaptive, Bayesian, and fixed trial design simulations within minutes, optimizing sample size and cost across Phase 1-3 studies including BOIN12, Seamless 2/3, and Response-Adaptive Randomization designs. Built for biopharma sponsors and CROs seeking faster, leaner trial protocols.
- Response Optimizer Causal machine learning module that detects heterogeneous treatment effects across covariates, identifies optimal responder subgroups and biomarkers, and supports trial rescue by pinpointing patients most likely to benefit from therapy. Built on PhaseV's published CARD (Causal Responder Detection) and Robust CATE ensemble methods.
- Portfolio Optimizer Causal disease modeling module that builds directed acyclic graphs (DAGs) from biomarkers and real-world data to quantify biomarker impact on clinical outcomes, identify key pathways and mediators, and run what-if scenario simulations for combination therapy assessment and indication expansion.
- ClinOps Optimizer Clinical operations module using causal machine learning for precision-guided site selection aligned with drug mechanism of action and patient heterogeneity, real-time enrollment and dropout tracking, patient progression analytics, and virtual control arm support.
- AI Conductor Centralized AI-powered platform launched in March 2026 that automates end-to-end protocol-to-submission clinical trial workflows, integrating regulatory compliance, data management, and collaboration features to reduce trial costs and improve success rates. Aimed at biopharma sponsors and CROs.
- AI-Powered Enrollment Lab Solution launched at the 17th Annual SCOPE Summit in February 2026 that uses real-world data and AI/ML to help sponsors assess and optimize clinical trial enrollment potential and feasibility before protocol lock.
- Tech-Enabled Services (Professional Services) Project-based engagements where sponsors and CROs contract PhaseV to deliver tech-enabled services with a dedicated team of ML, data-science, clinical and medical experts providing white-glove service throughout the project, layered on top of the SaaS modules.
Quantifiable outcome
- Up to 50% reduction in trial costs
- +6 more outcomes
Companies that use PhaseV
Customer profileNamed customers14 records
Segments5 records
Ideal customer profiles2 records
PhaseV technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability8 records
Feature11 records
PhaseV partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered charitable sponsorship partner, flagship cro channel partner, strategic data / disease-area partner, strategic co-development partner (gi), academic co-development partner, strategic co-development partner (oncology) and ecosystem distribution partner.
- Damon Runyon Cancer Research Foundationcharitable sponsorship partnerPhaseV sponsored the Timmerman Traverse at 'Mt. Emerson' level and pledged 5% of net revenues from all new oncology-related work in Q2 2026 to the foundation. Hamza Sheikh, PhaseV's VP of Business and Corporate Development, represented PhaseV on the trek. The Traverse has raised more than $3M for the foundation since 2023.
- Bioforumflagship cro channel partnerBioforum became the latest CRO to deploy PhaseV's AI trial design technology (per BioXconomy, Sept 2025); PhaseV and Bioforum announced a partnership to enhance clinical trials with AI/ML (per Clinical Trials Arena and Yahoo Finance).
- Crohn's & Colitis Foundationstrategic data / disease-area partnerPartnership to fast-track IBD clinical trials with AI; integrates data from the Foundation's IBD Plexus® with PhaseV's causal ML platform for site selection and trial execution.
- Alimentivstrategic co-development partner (gi)Partnership to support execution of adaptive clinical trials for GI; Alimentiv (GI-focused CRO) is integrating PhaseV's adaptive machine learning software with its GI therapeutic expertise.
- University Health Network (Toronto)academic co-development partnerCo-development agreement to advance machine learning-driven lupus research; part of DDW's 'Seven new drug discovery deals powered by AI' coverage (January 2025).
- Quanticateflagship cro channel partnerPartnership to deliver a new adaptive clinical trial service to sponsors; Quanticate is a PhaseV CRO channel partner helping sponsors run more adaptive trials using PhaseV's platform.
- iOMEDICOstrategic co-development partner (oncology)PhaseV and iOMEDICO partnered to launch a new ML-powered solution to increase success rates of Phase 3 oncology trials, combining causal inference with rich oncology real-world data for advanced covariate adjustment.
- 9xchange Biopharma Marketplaceecosystem distribution partnerPartnership to bring PhaseV's ML-powered clinical trial optimization technology to 9xchange ecosystem members; featured in PharmaShots interview with CEO Raviv Pryluk.
Scale indicators14 records
Recent moves8 records
Expansion highlights6 records
PhaseV competitors and assessment
Company assessmentBroad incumbents
- Medidata (Dassault Systèmes): Largest clinical trial technology platform (Rave EDC, RTSM, eCOA) used by most major sponsors. Direct adjacency to PhaseV in trial design/operations, but as part of a much broader CRO-aligned software suite rather than a focused AI-native offering.
- Veeva Systems: Enterprise cloud software for life sciences, including Veeva Vault Clinical Suite used by global biopharma for trial operations. Adjacent buyer base and overlapping workflows, though Veeva is broader than trial design AI.
- Oracle Health Sciences (Clinical One / Siebel CTMS): Incumbent EDC/CTMS vendor with a large installed base among biopharma sponsors; increasingly embedding analytics and AI features, competing for the same enterprise budget as PhaseV.
- IQVIA: Largest CRO with deep data assets and proprietary technology platforms touching nearly every sponsor; competes for the same enterprise budget and increasingly layers in AI-driven trial design and analytics.
Direct peers
- Cytel: Specialist in adaptive trial design, Bayesian statistics, and clinical trial software (East®) — directly comparable expertise to PhaseV's Trial Optimizer and adaptive-trial capabilities.
- Saama Technologies: AI-driven clinical trial analytics and data management platform for biopharma; comparable buyer base and overlapping use cases in trial operations and analytics.
Emerging players
- ConcertAI: AI platform for oncology real-world data and clinical trial optimization; competes with PhaseV's Response Optimizer and Portfolio Optimizer for biopharma AI budgets in oncology.
- Owkin: AI biotech applying ML to patient stratification and trial design for biopharma; partial overlap with PhaseV's HTE/subgroup identification capabilities.
- Flatiron Health: Oncology-specific real-world data and clinical trial technology company; comparable in combining curated clinical data with biopharma trial enablement, focused on oncology vs PhaseV's TA-agnostic approach.
- Trial Library / Mendel (rebrand candidates): AI platform for clinical trial feasibility, site selection, and protocol design; comparable in applying ML to clinical operations optimization, particularly for sponsor-side decisioning.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
PhaseV social profiles
Digital presencePhaseV compliance and trust
Trust signalCompliance4 records
PhaseV financial estimates
Financial estimateRevenue estimate
Valuation estimate
PhaseV leadership team
Management profileNumber of profiles
Profiles12 records
PhaseV funding detail
Funding detailFunding overview
Funding rounds2 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PhaseV 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 PhaseV
What does PhaseV do?
PhaseV provides an AI/ML-driven platform that helps biopharma sponsors and CROs design, optimize, and execute clinical trials more efficiently. The platform combines causal machine learning, Bayesian adaptive design, GenAI, and reinforcement learning on top of a 10M+ patient data lake to support trial simulation, heterogeneous treatment effect analysis, biomarker-driven portfolio decisions, and ML-driven site selection. Offerings are delivered as multi-module SaaS subscriptions (Trial Optimizer, Response Optimizer, Portfolio Optimizer, ClinOps Optimizer, AI Conductor) plus project-based tech-enabled services.
Is PhaseV a public or private company?
PhaseV is a private company. It is classified as venture growth investor backed and is currently operating.
When was PhaseV founded?
PhaseV was founded in 2023. It employs 51 to 100 people.
Where is PhaseV based?
PhaseV is headquartered in Boston, United States, in the North America region.
How does PhaseV make money?
Two revenue lines are on record. Tech-Enabled Services (Professional Services) is the primary driver. The others are software as a Service (SaaS) Subscription.
Who are PhaseV's main competitors?
Broad incumbents on record are Medidata (Dassault Systèmes), Veeva Systems, Oracle Health Sciences (Clinical One / Siebel CTMS) and IQVIA. Direct peers are Cytel and Saama Technologies. Emerging players are ConcertAI, Owkin, Flatiron Health and Trial Library / Mendel (rebrand candidates).
Does PhaseV have an API?
No public API is recorded for PhaseV.
What industry is PhaseV in?
PhaseV's product category is Clinical Trial Optimization Software. Its primary akta.pro industry code is HLAGAJAO, AI/ML Platforms for Drug Discovery & Experiment Optimization, with a secondary code of HLACAOAO, Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines). Its NAICS code is 541511 and its SIC code is 7372.