
trials.ai
AI-powered clinical study design automation with intelligent recommendations for protocol development, eligibility criteria, and operational optimization.
Overview
Trials.ai, developed by ZS, is an AI-powered clinical study design platform built for modern research teams in the life sciences industry. The platform leverages advanced agentic AI technology to digitize, automate, and add intelligence to every aspect of clinical trial creation — with the goal of increasing efficiency, shortening timelines, and ultimately delivering better patient outcomes.
Backed by ZS's 40+ years of life sciences expertise and a dedicated product team of over 900 members, Trials.ai serves more than 100 life science companies worldwide. The platform is grounded in the vision that optimized study designs should seamlessly feed upstream and downstream artifacts and systems across the clinical development lifecycle.
Core Applications
- Smart Designer: A full-featured application for building complete clinical studies with intelligent automation and AI-powered recommendations. It streamlines every step of the design process, from initial study setup through schedule of activities finalization.
- Library Manager: An application that provides access to reusable knowledge and language in a contextually relevant manner, enabling research teams to instantly tap into their organization's collective institutional wisdom.
Data Products
- Clinical Studies Ontology: A shared semantic framework containing 500,000+ BFO-compliant classes that connects clinical study concepts across documents and systems, enabling consistent and structured data interpretation.
- Banzai Pipeline: A rapid document digitization and data ingestion pipeline that uses NLP, named entity recognition (NER), and large language models (LLMs) to transform legacy protocols and study documents into structured, queryable data assets.
Franklin – AI Optimization Advisor
- Franklin is Trials.ai's AI optimization advisor, providing expert guidance across clinical science, biostatistics, regulatory strategy, and medical writing to help teams optimize study design in real time.
- Unlike tools focused primarily on protocol writing, Franklin emphasizes improving the underlying design decisions that shape the protocol — exploring alternatives across endpoints, eligibility criteria, schedules of activities, patient populations, and operational complexity before they become locked into downstream documents.
- Franklin is powered by structured study data connected through the Trials.ai ontology and Dynamic Data Graph, enabling it to reason across historical clinical trials, operational outcomes, and protocol design patterns to surface meaningful design insights — not just generate text.
- The system brings cross-functional expertise — spanning clinical science, biostatistics, regulatory strategy, protocol development, and clinical operations — into a single intelligence layer, helping teams evaluate tradeoffs across scientific, statistical, and operational dimensions.
- Franklin is named in honor of Rosalind Franklin, the pioneering chemist and X-ray crystallographer whose work helped reveal the structure of DNA, reflecting the platform's commitment to evidence-driven scientific rigor.
Intellectual Property and Compliance
- Trials.ai holds US Patent No. 11,328,795 covering intelligent planning, execution, and reporting of clinical trials, including the Patient Burden Index. The patent was invented by Kim Walpole, Thomas Walpole, and others, and is assigned to ZS Associates Inc.
- The Clinical Studies Ontology is built on BFO (Basic Formal Ontology)-compliant classes, ensuring a rigorous and interoperable semantic framework across clinical study concepts.
Trials.ai represents ZS's commitment to transforming clinical development through the combination of data-driven intelligence, next-generation technology, and deep domain expertise — partnering with the world's leading life sciences organizations to bring therapies to patients faster.