The Study Creation Problem
Building a clinical study today is a weeks-long, expertise-intensive process that produces - primarily - a document. Clinical scientists gather requirements, consult internal standards, review literature, and translate everything into a protocol that will eventually be manually replicated across dozens of downstream documents and systems.
The inefficiency is systemic and familiar to everyone in clinical development. Every team has experienced the protocol amendment that traces back to an inconsistency between the study design document and the eCRF. Every medical writer has manually populated study details into template after template. Every data manager has re-entered eligibility criteria from a Word document into a clinical trial management system - and wondered why this cannot be automated.
Smart Designer was built to address this - starting from the first moment of study design, treating the protocol as a data asset rather than a document from day one.
"Smart Designer is not a protocol authoring tool. It is a study design platform that happens to generate documents - because the structured data it creates makes document generation a natural output, not a separate process."
The Workflow: Four Stages
Study Setup
Define the foundational elements of your study: indication, therapy area, phase, objectives, endpoints, eligibility criteria, study arms, and design parameters. Smart Designer draws on the Clinical Studies Ontology to provide contextually relevant suggestions throughout setup - endpoint recommendations grounded in therapy area standards, eligibility criteria linked to standard terminology, and design parameters benchmarked against similar historic studies. The result is a structured data object, not a draft document.
Schedule of Activities
Build your Schedule of Activities with AI-powered autogeneration: based on the study parameters from setup, Smart Designer generates a draft schedule that teams refine rather than build from scratch. Franklin Connected Intelligence surfaces real-time benchmark comparisons and burden scoring as the schedule evolves - flagging high-burden procedures, comparing visit counts against similar studies, and recommending schedule optimizations before design is finalized. eSoA scenario modeling enables side-by-side comparison of schedule alternatives.
Optimization
Before finalizing the protocol, Smart Designer's optimization layer enables teams to actively improve the design based on objective metrics. Patient burden optimization identifies high-burden procedures and visit clusters that can be restructured without compromising scientific integrity. Cost modeling estimates activity-level costs using Medicare data and industry benchmarks. Franklin provides structured recommendations grounded in benchmark data - specific, evidence-based suggestions with supporting rationale.
Finalize and Connect
When the study design is finalized, Smart Designer converts the structured study data into first drafts of essential documents and system connections - in a single step. Protocol synopsis, safety monitoring plan, informed consent form, RACT, investigator brochures, and 80+ additional document templates are populated with study-specific data. API and MCP connections to EDC platforms, clinical trial management systems, regulatory submission tools, and other downstream systems are established automatically.
Key Capabilities
- Study schedule autogeneration from context provided during study setup
- Real-time, contextually relevant AI recommendations from the Clinical Studies Ontology
- eSoA scenario modeling with patient burden and cost at activity, visit, and schedule levels
- Benchmark filtering and comparison against thousands of historic studies
- Franklin Connected Intelligence for guided exploration and tradeoff analysis
- Data visualizations with Franklin-guided real-time interpretation
- Study data integration with automated content population across documents
- GenAI-powered section automation for protocol narrative sections
- Content standards enforcement and reuse from the Library Manager
- Collaborative workflow with review, commenting, and approval routing
- Export to Microsoft Word and 80+ downstream document templates
- API and MCP connections to IQVIA, Medidata, CT.gov, and other clinical systems
The Time Savings
Teams using Smart Designer report significant reductions in study build time across the design workflow. The combination of schedule autogeneration, AI-powered recommendations, and automated downstream document population eliminates weeks of manual work from the study design process. Organizations typically see 6–8 weeks of time savings per study across the design and document generation phases.
More importantly, the structured data approach reduces the inconsistency and error rate that leads to protocol amendments. When the protocol is a data object rather than a document, downstream systems receive consistent, validated information - not manually transcribed approximations. Teams that have experienced avoidable amendments driven by protocol-to-system inconsistency understand the value of this consistency acutely.
Getting Started
Smart Designer is available now as part of the Trials.ai platform. Implementation typically begins with a structured onboarding process that includes integration of your organization's content standards into the Library Manager, configuration of downstream system connections, and training for clinical scientists and medical writers.
We offer a personalized demo tailored to your organization's therapy area focus and current study design workflow. To schedule a walkthrough, contact us using the link below.