SOLUTIONS

Smarter studies don't happen in point solutions

Whether you're a clinical scientist designing protocols, a medical writer authoring documents, or a data team building analytics - Trials.ai meets you where you are.

SMART DESIGNER

End-to-end clinical study design and document generation

Smart Designer empowers teams to build optimized clinical studies and generate protocol documents with AI-driven recommendations, benchmark comparisons, and real-time tradeoff analysis. From study setup to protocol draft, streamline the entire workflow.

Study schedule autogeneration from context provided in study setup
Real-time, contextually relevant recommendations from our AI engine
eSoA scenario modeling with patient burden and cost at activity, visit, and schedule levels
Benchmark filtering and comparison against historic studies
Franklin Connected Intelligence for guided exploration and tradeoff analysis
Data visualizations with real-time Franklin-guided interpretation
Study data integration with automated content population across documents
GenAI-powered section automation and generation
Content standards enforcement and reuse
Collaborative workflow with review and approval
Export to Microsoft Word and 80+ downstream document templates

HOW IT WORKS

Design → Optimize → Finalize & Connect

Design

Build your clinical study leveraging intelligent automation and contextually relevant suggestions from our recommendation engine.

Optimize

Build your Schedule of Activities. Optimize in real-time with cost, patient burden, and schedule trade-offs along the way.

Finalize & Connect

Send to 80+ downstream documents and systems for seamless automation with the click of a button.

DATA AS A SERVICE

License our data assets

Build custom solutions with our proven clinical intelligence. Available for integration into your platforms and applications.

Clinical Studies Ontology

500K+ BFO-compliant classes integrating CDISC, USDM, and industry standards

Patient Burden Index

Validated scoring model proven to correlate with operational outcomes

Study Cost Data

Activity-level cost analytics using Medicare data and industry benchmarks

Benchmark Database

Historic study data for comparison, modeling, and ML training

CLINICAL STUDIES ONTOLOGY

The semantic foundation for intelligent clinical trial design

The Clinical Studies Ontology is a 500K+ class knowledge framework that connects clinical study concepts across documents, standards, and systems. Built on BFO standards and integrating the industry's leading terminologies, it powers every AI recommendation, benchmark comparison, and contextual suggestion across the Trials.ai platform.

500K+ BFO-compliant classes covering every aspect of clinical study design
Native integration with CDISC, USDM, HL7 FHIR, SDTM, and NCI standards
OMOP/OHDSI, SNOMED, MedDRA, LOINC, and ICH M11 terminology support
Cross-document semantic linking for reusable statements and language
Foundation for contextually relevant AI recommendations
Extensible to include organizational standards and custom terminology
Powers the Dynamic Data Graph connecting all study data nodes
Licensable as a standalone data asset via DaaS

LIBRARY MANAGER Coming Soon

Centralized content standards and ontology management

Library Manager empowers clinical data standards teams to manage content standards, curate life sciences ontologies, and govern reusable language across your organization. A single source of truth for clinical terminology, document templates, and study content.

Manage and version control organizational content standards
Curate and extend the Clinical Studies Ontology for your organization
Create and maintain reusable statement libraries
Define terminology mappings across CDISC, SNOMED, and internal standards
Collaborate across data standards, medical writing, and clinical teams
Audit trail and approval workflows for standard changes
Push updates to downstream documents and systems automatically