Trials.ai

What Trials.ai does

Trial.ai, a wholly-owned subsidiary of ZS Associates headquartered in Princeton, New Jersey (originally founded in San Diego in 2018), provides an AI-powered clinical study design platform for pharmaceutical, biotechnology, and clinical research organizations. Its core products—Smart Designer (end-to-end study design application), Library Manager (content standards and ontology management), Franklin Connected Intelligence (AI Optimization Advisor), and supporting data products including a 500K+ BFO-compliant Clinical Studies Ontology, the Banzai NLP/NER/LLM ingestion pipeline, and the Dynamic Data Graph—are built around the architectural principle that clinical protocols should be treated as structured data assets rather than Word documents. This enables AI-powered recommendations, real-time Patient Burden Index scoring (validated with Tufts CSDD), and automated generation of 80+ downstream document templates and system integrations with IQVIA, Medidata, ClinicalTrials.gov, EDC, and eCOA platforms.

The platform is monetized through quote-based enterprise subscriptions with annual billing, supplemented by implementation/professional services and a Data as a Service (DaaS) offering that licenses benchmark data, study cost data, and the Patient Burden Index. The go-to-market is sales-led and enterprise-focused: prospective customers request personalized demos and engage with subject-matter experts, with distribution enabled by ZS's global network of 35+ offices and 100+ life science clients including top-20 global pharmaceutical companies. The company holds US Patent No. 11,328,795 covering Intelligent Planning, Execution, and Reporting of Clinical Trials (including the Patient Burden Index), is a founding contributor to TransCelerate's Unified Study Definitions Model (USDM) initiative, and maintains approximately 40 dedicated team members operating under the "Trials.ai by ZS" brand.

Name

Trials.ai

Legal name

Trials.ai, a ZS company

Website

https://trials.ai

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Trial.ai, a ZS Associates subsidiary, provides an AI-native clinical study design platform that treats protocols as structured data assets. Its Smart Designer, Franklin AI, and 500K-class Clinical Studies Ontology serve top-20 pharmaceutical companies, optimizing study design and reducing patient burden.

Ownership category

akta.pro rank

Product category

Clinical Trial Design Software

NAICS

Software Publishers (513210), Scientific Research and Development Services (5417)

SIC

Services-Prepackaged Software (7372), Services-Computer Integrated Systems Design (7373)

akta.pro primary industry

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO)

akta.pro secondary industries

Electronic Data Capture (EDC) Platforms (HLACAOAA), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Clinical trial design
• Protocol optimization software
• AI clinical development
• Patient burden analytics
• Clinical study automation

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations

Revenue model

1. Platform SaaS/Subscription: AI-powered clinical study design platform offered as subscription to pharmaceutical and biotech companies. Includes Smart Designer, Franklin AI, and downstream connections.
2. Data as a Service (DaaS): Licensing of data assets including Patient Burden Index, Study Cost Data, Benchmark Database, and Clinical Studies Ontology for integration into customer platforms and applications.
3. Professional Services: Implementation services including integration of organizational content standards, downstream system connections, and training for clinical scientists and medical writers.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Trials.ai sells an AI-powered clinical study design platform that treats clinical protocols as structured data assets rather than Word documents. Its Smart Designer application builds optimized protocols with AI-powered recommendations, automated generation of 80+ downstream documents, and integrations to EDC, eCOA, IQVIA, Medidata, and ClinicalTrials.gov. The platform is licensed to pharmaceutical and biotech companies via enterprise subscription.

Product overview

Trials.ai offers an AI-powered clinical development platform comprising four core products: Smart Designer (end-to-end study design and document generation application), Library Manager (content standards and ontology management), Clinical Studies Ontology (500K+ class knowledge framework), and Banzai Pipeline (NLP/LLM-powered document digitization). The platform is unified by Franklin Connected Intelligence, an AI assistant layer embedded within Smart Designer that provides real-time guidance across clinical science, biostatistics, and regulatory strategy. Supporting data products include the Dynamic Data Graph and Data as a Service offerings. The platform treats the protocol as a data asset rather than a document, enabling automated downstream connections to 80+ document templates and clinical systems.

Differentiator

Problem solved

Functional benefit

Brands

• Smart Designer: AI-powered end-to-end clinical study design and document generation application
• Library Manager
• Franklin
• Clinical Studies Ontology
• Banzai Pipeline

Products and services

• Smart Designer

Quantifiable outcome

• Up to 8 weeks reduction in study build time with AI-powered design and automated downstream connections
• +4 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

AI capability7 records

Feature7 records

Partnerships

Seven partnerships are on record, tiered strategic and core.

• Tufts Center for the Study of Drug DevelopmentstrategicStrategic or Co-development Partner · 1 January 2026Research collaboration validating the Patient Burden Index as a predictor of operational outcomes. Tufts' longitudinal database of clinical trial performance data linked to burden scores for statistical validation. Collaboration revealed statistically significant correlations: 34% higher dropout rates in highest burden quartile, 22% increase in screen failure with high-burden visit clustering, 18% shorter enrollment timelines for burden-optimized studies.
• IQVIAcoreTechnology or IntegrationAPI and MCP integration connecting Trials.ai platform to IQVIA clinical systems for seamless data flow between study design and execution.
• Medidata SolutionscoreTechnology or IntegrationIntegration with Medidata's clinical trial platform enabling connection between protocol design and EDC systems.
• ClinicalTrials.govcoreTechnology or IntegrationDirect connection to ClinicalTrials.gov for study registration and data synchronization.
• TransCeleratestrategicStrategic or Co-development PartnerFounding contributor to TransCelerate Unified Study Definitions Model (USDM) initiative. Active participant in USDM working groups since inception, helping shape the standard for machine-readable clinical study protocols. Clinical Studies Ontology natively aligns with USDM concepts.
• EDC System IntegrationscoreTechnology or IntegrationAPI and MCP connections to Electronic Data Capture (EDC) platforms for automated study data configuration and bidirectional data flow.
• eCOA System IntegrationscoreTechnology or IntegrationIntegration with electronic Clinical Outcome Assessment platforms for seamless connection between protocol design and patient-reported outcomes.

Scale indicators10 records

Recent moves8 records

Expansion highlights6 records

Market position

Competitive moat6 records

Key risks6 records

Customer concentration

• LinkedInlinkedin.com/company/trials.ai
• Xx.com/trialsAI

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds6 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Trials.ai