AI-assisted design. Human approval. Controlled compilation.
A governed protocol-to-study architecture: AI helps understand and design the study, accountable users approve the controlled blueprint, and module compilers produce executable clinical application configurations.
Separate interpretation from execution.
The architecture deliberately distinguishes AI-generated proposals from approved study intelligence and executable configuration.
Clinical protocol and study documents
The study starts with the approved protocol and relevant controlled source documents.
Extract study facts and propose configuration
GarudaSphere AI identifies visits, assessments, eligibility, endpoints, treatment, safety, randomization and operational requirements, and can propose module-specific designs.
Review, correct and approve
Authorized clinical users verify the AI interpretation and proposed designs. Approved decisions become attributable study records.
Versioned canonical study model
The approved blueprint becomes the controlled study source used by validation services and module compilers.
Validate constraints and compile modules
Clinical design knowledge, deterministic rules, dependency checks and module-specific compilers translate the approved blueprint into executable configurations.
Run the study across GarudaSphere applications
CTMS, EDC, eTMF, eISF, RTSM/IP, ePRO and eConsent execute from a shared study context with traceability back to the approved blueprint.
Each module has its own specialized compiler.
The approved Digital Study Blueprint is not a finished application. Each compiler applies domain-specific rules and produces the configuration required by its runtime engine.
EDC Compiler
Transforms approved visit, assessment and data requirements into forms, fields, codelists, edit checks, calculations, conditional logic and visit mappings.
CTMS Compiler
Builds milestones, site activities, monitoring expectations, task structures, dependencies and operational workflows.
TMF / ISF Compiler
Creates expected-document structures, applicability, metadata, lifecycle requirements and site-specific filing plans.
RTSM / IP Compiler
Creates approved cohort, allocation, kit, dispensing, accountability and reconciliation configurations.
Cross-module consistency by design.
When the protocol defines a visit, assessment, cohort, endpoint or treatment requirement, the approved study model can provide the same source context to every relevant compiler rather than requiring separate manual interpretation.
Study Blueprint
AI is the intelligence layer—not an uncontrolled deployment path.
Explore how GarudaSphere uses AI to interpret, propose and assist while keeping approved configuration under controlled system governance.