From Prediction to Proof.
Risk-based activation intelligence — powered by Celina. Identify risk before it's realized. Verify compliance before it's submitted. Prove outcomes after they're delivered.
Regulators Are Already Asking for This.
NexTrial didn't invent risk-based quality management. Regulators mandated it. We built the infrastructure that makes it executable.
FDA AI Guidance (January 2025)
The FDA now requires 'model credibility' for AI systems used in clinical trials. Black-box AI is being rejected. Deterministic, explainable AI — the kind NexTrial builds — is what regulators want to see.
ICH E6(R3) — Risk-Based Quality Management
The new ICH GCP guidelines mandate risk-based approaches to clinical trial quality. RBQM is no longer optional — it's the framework. NexTrial's predict-activate-prove architecture is how sponsors operationalize it.
ANVISA Lei 14.874/2024
Brazil's new clinical research law modernizes the regulatory framework and creates an 18-month window for first movers. NexTrial's ANVISA Blueprint is the only AI platform fully encoded for Brazilian regulatory compliance.
Every Patient Is a Differential Equation.
Feasibility isn't a survey. Eligibility isn't a snapshot. Celina models patient trajectories and site readiness as continuous flows — predicting who will enroll, who will complete, and where the risks hide.
FQG+ — Feasibility Qualification Graph
Traditional feasibility relies on historical averages and self-reported capabilities. FQG+ replaces opinion with infrastructure.
FQG+ scores site readiness across six dimensions: patient access, staff capability, equipment availability, regulatory compliance posture, historical performance, and enrollment velocity potential.
The result: sponsors know which sites will actually enroll before committing activation budget. Site networks know their readiness score before the RFP arrives.
Rejection rate: 25-30% industry → <5% with FQG+ validated sites
Patient Trajectory Intelligence
Competitors match patients to trials based on today's snapshot. Celina models eligibility as a trajectory over time.
Screen failure probability. Dropout risk curves. Completion windows. Enrollment velocity by site. Every patient modeled as a differential equation — not a binary yes/no.
This is physics-informed prediction: the same mathematical discipline used in fluid dynamics and atmospheric science, applied to clinical trial enrollment.
90 → 38 day activation includes trajectory-informed site selection
Verified. Not Estimated.
Trial Activation Intelligence compresses the 120-day maze between protocol and First Patient In. Not by moving faster through the maze — by eliminating the obstacles that create it.
Deterministic Regulatory Verification
Every regulatory packet is verified against jurisdiction-specific requirements before submission. Not confidence scores. Proof certificates. 94% first-submission approval where the industry averages 70%.
Multi-Jurisdiction Country Blueprints
FDA. ANVISA. CDSCO. Each Country Blueprint encodes 6-12 months of jurisdiction-specific regulatory knowledge — requirements, validation logic, and approval pathways. EU CTR and NMPA in development.
Zero-Rejection Architecture
IRB packet preparation drops from 3-6 weeks to 3-5 days. Coordinator compliance burden drops from 10-12 hours/week to under 2. Every document is audit-ready with traceable lineage.
90 → 38 days | 94% approval | 3 jurisdictions active
TAI Gets You Started. TEI Proves What Happened.
Trial Activation Intelligence gets you to First Patient In. Trial Execution Intelligence carries you to First Patient Out. The proof layer that completes the loop.
Plan vs. Actual Tracking
Real-time comparison of planned enrollment against actual performance. Site-level variance detection.
Enrollment Velocity Monitoring
Continuous measurement of enrollment speed by site, by region, by cohort. Early warning when velocity drops.
Deviation Detection
Protocol deviations identified as they emerge — not after audit. Risk-based quality signals before they become findings.
Execution Telemetry
The complete operational record: what happened, when, where, and why. Audit-ready from day one.
TEI closes the loop. Prediction feeds activation. Activation feeds execution. Execution feeds back into prediction. Every trial makes the next one smarter.
Three Moats. Not Features.
Provably Right, Not Probably Right
Competitors generate documents and assign confidence scores. Celina generates documents and verifies them deterministically against jurisdiction-specific regulatory requirements before submission. Every output has a traceable verification chain — not a probability estimate.
94% first-submission approval vs. 70-75% industry average
18-36 Months Competitors Can't Skip
Each Country Blueprint encodes 6-12 months of jurisdiction-specific regulatory knowledge. We've built three. Competitors starting today need 18-36 months to replicate what's already live. Every new jurisdiction extends the gap.
We Will Never Store a Document. We Will Never Capture a Data Point.
Celina orchestrates — your systems govern storage, your teams own decisions, your patients stay protected. This isn't a privacy policy. It's architecture. While competitors build data moats by capturing your information, we build trust moats by refusing to.
See How This Applies to You
Celina orchestrates. Humans decide. Patients get access.
Category-defining essays on the future of clinical trial infrastructure. Monthly.
DIA 2026 · Philadelphia · June 14-18 · Abstract ID 116114