AI can help propose protocol-specific designs for every GarudaSphere application. Qualified users approve the study blueprint, then specialized compilers create the controlled executable configuration for each module.
Plan and oversee studies, sites, milestones, monitoring, issues, actions and operational status from one connected workspace.
Study milestones, visit timelines, site activities, monitoring requirements, task structures and operational dependencies.
The approved blueprint into controlled CTMS milestones, workflows, responsibilities, dependencies and study-level operational configuration.
Protocol-specific data capture with participant visits, eCRFs, edit checks, discrepancy management, SDV, investigator sign-off and database-lock workflows.
eCRFs, sections, data fields, codelists, visit mappings, derivations, programmed edit checks, conditional logic and query messages.
Approved design objects into validated executable EDC metadata consumed by the Capture runtime engine.
Manage essential trial records with metadata, completeness oversight, lifecycle control and inspection-readiness workflows.
Expected-document plans, study-specific applicability, document metadata, milestone linkage and completeness requirements.
The approved record plan into controlled TMF structures, expected-document placeholders and lifecycle configuration.
Give investigator sites a focused workspace for essential documents, study tasks, communication and site-file status.
Site-specific document expectations, task schedules, training requirements and filing dependencies.
Approved requirements into site workspaces, expected records and controlled site-level workflows.
Support controlled randomization, treatment allocation and study-specific assignment workflows connected to participant and supply context.
Cohort structures, allocation ratios, stratification factors, visit eligibility and assignment requirements extracted from the protocol.
The approved randomization specification into controlled RTSM configuration and assignment workflows.
Track investigational product shipment, receipt, dispensing, return, accountability, reconciliation and exception status.
Dispensing schedules, kit quantities, accountability expectations, return rules, reconciliation logic and protocol-linked supply events.
Approved supply design into executable IP workflows connected to participant visits and RTSM assignments.
Collect participant-reported outcomes according to protocol schedules and connect them to study data and follow-up workflows.
Assessment schedules, questionnaire timing, reminders, completion windows and study-specific participant instructions.
The approved participant-assessment design into controlled ePRO schedules and participant workflows.
Support digital informed-consent workflows with version control, participant traceability, review status and study integration.
Consent pathways, version dependencies, re-consent triggers, participant steps and study-specific workflow requirements.
Approved consent design into controlled participant and investigator eConsent workflows.
Because compilers consume the same approved study blueprint, GarudaSphere can maintain relationships between protocol requirements and the application configurations that depend on them.
Explore the GarudaSphere intelligence architecture that separates AI proposals, human governance and controlled module compilation.