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The Clinical Trial Decisioning System

Outdefine helps clinical teams accelerate site feasibility, monitor study risk, and improve decisions with every outcome — using governed data, trial-trained inference, and controlled workflow agents.

PatientDataProtocolRulesSiteHistoryClinicalSignalsAI ENGINEDecision LoopsFeasibilitySite RankingsStudy HealthRisk AlertsOutcomesRWE LearningActive Learning Feedback LoopACTIVE

Decisioning Across the Clinical Trial Execution Loop

847 eligible sites94#1Memorial87General78Regional65Metro

Feasibility & Site Selection

Rank sites by patient fit, site performance, and enrollment risk — producing a defensible shortlist for faster feasibility decisions.

1 Alert Active · Study NCT-2024-481ENROLL87%SAE/AE100%PROTOCOL98%DATA92%

Study Health & Risk Monitoring

Flag site risk, enrollment lag, protocol deviations, missing data, and safety signals — then recommend the owner and next-best action.

RWDn=12,400Syntheticn=18,200Trial Datan=10,600Multi-source synthesis

Real-World Evidence & Synthetic Cohorts

Identify cohorts, eligibility gaps, and reusable evidence signals from patient footprint and RWD/E.

Outdefine Execute Turns Trial Data Into Governed Decisions

Execute sits above existing clinical systems as the governed decisioning and execution layer — connecting trial data, protocol rules, workflow agents, human actions, and outcomes so every decision improves over time.

INPUTSTrial DataPatient · ProtocolRules EngineGovernance · LogicHuman ActionsDecisions · ReviewsWORKFLOWSExecuteMonitorAnalyzeLearnOUTCOMESFeasibilitySite SelectionStudy HealthReal-time InsightsRWE AnalysisEvidence GenerationLearning Loop

Faster Startup. Healthier Studies. Better Decisions

BEFORE16 weeks5× fasterAFTER3 weeks

From Manual Feasibility to Faster Site Decisions

Compress feasibility cycles by unifying protocol criteria, patient footprint, site performance, and recruitment signals into one governed workflow.

Deployment+65%

Continuous Learning From Actions & Outcomes

Each deployment captures recommendations, human actions, study outcomes, and feedback signals — improving future site, risk, and intervention decisions.

CoreMonitoringSite OpsRWEFeasibilitySafetyProtocol1 → N workflows

Scalable Without Transformation

Start with one high-value workflow — site feasibility, study monitoring, or RWE — then expand across adjacent trial operations using the same patient, protocol, site, and outcome data layer.

Built for Regulated Clinical and Healthcare Environments

Outdefine brings experience across AI infrastructure, healthcare systems, life sciences operations, and regulated enterprise deployments — built for environments where data boundaries, governance, auditability, and workflow approvals matter

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Deploy Governed Decisioning Across Your Clinical Trial Workflows

Partner with Outdefine to accelerate site feasibility, monitor study risk, and build governed decisioning workflows from your existing clinical, patient, protocol, and operational data.