From protocol to an approved, executable digital trial.
AI interprets the protocol and proposes study designs. Clinical experts approve. The Study Intelligence Core validates and compiles connected clinical applications.
AI accelerates design.
Accountable users stay in control.
AI-generated interpretations and module designs remain proposals until an authorized user reviews and approves the study blueprint. Executable configurations are then produced through controlled compilers.
AI Proposes
Protocol facts, eCRF designs, edit checks, milestones, document requirements and other study-specific configurations can be proposed using AI.
Experts Approve
Qualified users verify, correct, accept or reject proposed study elements before they become part of the approved Digital Study Blueprint.
GarudaSphere Compiles
Validated module compilers transform the approved blueprint into controlled, executable configurations for each clinical application.
One visual path from source to execution.
GarudaSphere separates interpretation from execution: proposals stay reviewable until approved, then compilers produce attributable module configurations.
One protocol. One reviewed model. Many applications.
The protocol is interpreted once into a shared digital study blueprint, governed through expert review before module-specific compilation.
Ingest
Upload the approved protocol and relevant study-design documents.
Interpret
AI extracts clinical and operational requirements with source context.
Review
Clinical experts verify, correct and complete the proposed design.
Approve
Create the controlled, versioned Digital Study Blueprint.
Compile
Run EDC, CTMS, TMF, RTSM, ePRO and other module compilers.
Execute
Launch connected applications from the same approved context.
The controlled bridge between AI and execution.
GarudaSphere separates AI-assisted interpretation from executable system configuration. The Study Intelligence Core maintains the approved study model, applies clinical design knowledge, validates constraints and feeds module compilers.
Intelligence that stays with the trial.
Cortex connects protocol understanding, document intelligence, operational watch and conversational assistance—without removing accountable human control.
12 of 20 participants enrolled (60%). 2 screen failures this week. Next scheduled screening visit: tomorrow 10:30.
Purpose-built modules. Compiled from one approved context.
Each application has its own domain logic and compiler while remaining connected to the same approved Digital Study Blueprint.
TrialOps
AI-assisted operational design, then controlled compilation of milestones, site activities, monitoring and workflows.
Capture
AI-assisted eCRF and edit-check proposals, reviewed and compiled into executable EDC configuration.
Vault
Study-specific essential-record plans and metadata structures compiled into a controlled TMF workspace.
SiteVault
Protocol- and site-specific document expectations, tasks and essential-file workflows.
Allocate
Reviewed cohort, randomization and assignment logic compiled into controlled treatment workflows.
Supply
Study-specific dispensing, accountability, return and reconciliation rules connected to the approved design.
Voice
Participant assessments and schedules proposed from the protocol and compiled into participant workflows.
Consent
Study-specific consent journeys, versions and review requirements within controlled digital workflows.
Design. Approve. Compile. Execute. Watch. Close.
GarudaSphere keeps study context connected from the first protocol interpretation through controlled setup, day-to-day execution and study closeout.
Protocol interpretation and study-specific proposals.
Expert review, correction, approval and version control.
Module compilers create executable configurations.
Sites, participants, data, documents and supply workflows.
Sentinel and Garuda surface context, risk and actions.
Reconciliation, sign-off, lock and archive readiness.
AI-assisted. Human-governed. Compiler-controlled.
Designed for regulated clinical research—with accountable review before consequential configuration and traceability from protocol source to deployed study setup.
Proposal is not execution.
Turn protocol intelligence into controlled trial execution.
See how AI-assisted study design, expert governance and controlled module compilation can shorten setup while keeping clinical teams in control.