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 Keeps You Right.
Celina Sends
When a protocol enters Celina, she generates a verified Schedule of Activities and a patient recruitment plan — every visit, every procedure, every assessment, mapped against the protocol using USDM 3.0 structured definitions. These flow directly to your CTMS and EDC for execution. Your coordinators work from verified plans. Your recruiters work from intelligence-driven strategies. Celina sends the intelligence. Your systems run the trial.
Celina Receives & Improves
As your trial executes, Celina reads screening data, enrollment velocity, deviations, and queries back from your EDC and quality systems. She analyzes screen-fail patterns to improve site selection for your next trial. She identifies protocol risks and suggests mitigation controls before deviations become findings. Every site's execution data sharpens the prediction model for the next site. The loop never breaks.
Your systems hold the data. Celina holds the intelligence. She sends verified plans out. She reads execution signals back. She never stores a document. Never captures a data point. Your CTMS is the system of record. Your EDC owns the data. Celina makes them both smarter — trial after trial.
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