Smart Designer

Smart Designer, part of the Trials.ai platform by ZS, is an end-to-end clinical study design and document generation solution built for clinical scientists, medical writers, data teams, and enterprise leaders. It empowers teams to build optimized clinical studies and generate protocol documents using AI-driven recommendations, benchmark comparisons, and real-time tradeoff analysis — covering the entire workflow from initial study setup through to a finalized protocol draft.

Unlike point solutions, Smart Designer is designed to meet every stakeholder where they are, integrating intelligent automation, content standards, and collaborative workflows into a single connected experience across the clinical trial design lifecycle.

Core Features and Capabilities

• Study schedule autogeneration based on context provided during study setup
• Real-time, contextually relevant recommendations delivered by the platform's AI engine
• eSoA (Schedule of Activities) scenario modeling with patient burden and cost analysis at the activity, visit, and schedule levels
• Benchmark filtering and comparison against a database of 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 for protocol documents
• Content standards enforcement and reuse across the organization
• Collaborative workflow with built-in review and approval processes
• Export to Microsoft Word and over 80 downstream document templates

How Smart Designer Works

1. Design: Build your clinical study by leveraging intelligent automation and contextually relevant suggestions from the recommendation engine, ensuring study setup is informed and efficient from the start.
2. Optimize: Construct your Schedule of Activities and optimize it in real time, balancing cost, patient burden, and schedule tradeoffs throughout the process.
3. Finalize and Connect: With a single action, send the finalized study data to over 80 downstream documents and systems for seamless, automated content population.

Clinical Studies Ontology — The Semantic Foundation

Underpinning Smart Designer is the Clinical Studies Ontology, a 500,000+ class knowledge framework that connects clinical study concepts across documents, standards, and systems. 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
• Support for OMOP/OHDSI, SNOMED, MedDRA, LOINC, and ICH M11 terminologies
• Cross-document semantic linking enabling reusable statements and language
• Extensible to incorporate organizational standards and custom terminology
• Powers the Dynamic Data Graph connecting all study data nodes
• Available as a standalone licensable data asset via the Data as a Service (DaaS) offering

Data as a Service — Licensable Clinical Intelligence

• Clinical Studies Ontology: 500K+ BFO-compliant classes integrating CDISC, USDM, and industry standards, available for integration into external platforms and applications
• Patient Burden Index: A validated scoring model proven to correlate with operational outcomes
• Study Cost Data: Activity-level cost analytics derived from Medicare data and industry benchmarks
• Benchmark Database: Historic study data suitable for comparison, modeling, and machine learning training

Library Manager — Coming Soon

• Centralized management and version control of organizational content standards
• Curation and extension of the Clinical Studies Ontology for organizational needs
• Creation and maintenance of reusable statement libraries
• Terminology mapping across CDISC, SNOMED, and internal standards
• Cross-team collaboration spanning data standards, medical writing, and clinical functions
• Audit trail and approval workflows for managing standard changes
• Automatic propagation of updates to downstream documents and systems

Trials.ai by ZS is built to support enterprise clinical teams with a connected, standards-compliant platform. Its Clinical Studies Ontology is licensable as a standalone data asset, and the platform's architecture supports integration with leading industry standards including CDISC, HL7 FHIR, USDM, and ICH M11, making it suitable for organizations seeking both out-of-the-box AI capabilities and extensible, enterprise-grade clinical intelligence infrastructure.