Predictable First Patient In. Across Every Jurisdiction.
Trial Activation Intelligence (TAI) compresses activation from 120 days to 30-45. Your trials start faster, your burn rate drops, patients get access.
The Math That Keeps Clinical Operations Up at Night
Phase III direct costs
enrollment burn
average activation
What Goes Wrong Between Protocol and First Patient
Overly complex eligibility criteria
14 inclusion flags that conflict with the site's actual patient population. Screen failures start on day one.
Unrealistic visit schedules
Visit frequency that doesn't align with site operational capacity. Coordinators fall behind before enrollment opens.
Jurisdiction mismatches
Regulatory requirements written for one jurisdiction applied to another. Submissions rejected on structural errors.
Feasibility gaps discovered after activation starts
Site limitations that should have been caught during qualification surface after budget is committed.
Amendments that reset the clock
Protocol changes triggered by problems that were predictable. Each amendment adds 3-6 months and $500K+.
Every one of these is preventable. Celina catches them before activation starts — not after they cost you months and millions.
How do you trust AI output in a regulatory submission?
Three-Gate Verification
Regulatory Compliance
Celina's regulatory foundation model checks compliance against jurisdiction-specific rules.
Structural Validation
Structural proof validation confirms the output is internally consistent.
Human Approval
Your team reviews and approves before anything is submitted.
No output reaches a regulator without passing all three gates.
"Human-in-the-loop is architecture, not policy."
Without Celina
Phase III direct costs. Per day. Compounding.
Every link in that chain is preventable.
With Celina
90 → 38 days. Predictable.
Protocol In → First Patient In
Protocol Intelligence
Your protocol parsed into structured regulatory requirements within hours
Jurisdiction Mapping
Simultaneous jurisdiction mapping — one protocol launches across FDA, ANVISA, CDSCO. EU CTR, NMPA, and additional jurisdictions in development.
Site Validation
Site readiness validated before you commit budget
Audit-Ready Activation
Audit-ready packets submitted — lineage preserved, First Patient In predicted with confidence bands
activation compression
first-submission approval
“Sponsors require predictability, not dashboards.”
Works With Your Existing Stack
Integrates with Veeva, Medidata, existing CTMS via API-first architecture
Plugin boundary: we orchestrate, your systems govern. We never store a document, never capture a data point.
Human-in-the-loop by design — Celina recommends, your team decides
Taking Your Trial to Brazil or India? Celina Already Speaks the Language.
Entering a new jurisdiction isn't just translation. It's regulatory transformation. Your FDA-designed protocol must be validated against an entirely different regulatory framework — different submission requirements, different ethics review structures, different data protection rules, different timelines.
Celina's Country Blueprints encode the complete regulatory architecture of each target jurisdiction. When your protocol enters Celina, she assesses it against the destination country's current regulations and identifies every compliance gap, submission requirement, and structural mismatch — before you file.
Brazil Entry via ANVISA
ANVISA's RDC 945/2024 and Lei 14.874/2024 have modernized Brazil's clinical trial framework and introduced regulatory reliance pathways — meaning prior FDA approval can accelerate your ANVISA review. But reliance doesn't mean automatic approval. Your protocol still needs ANVISA-specific DDCM and DEEC submissions, SINEP ethics coordination, and LGPD data protection compliance.
Celina validates your protocol against the complete Brazilian regulatory stack: RDC 945/2024 submission requirements, SINEP dual ethics review coordination, LGPD data localization compliance, and RDC 997/2025 optimized reliance queue eligibility. Three-Gate verification ensures every document meets ANVISA standards before submission — not after rejection.
ANVISA is actively attracting Phase 1 and Phase 2 international trials. The regulatory window is open. Celina ensures you walk through it with verified compliance.
India Entry via CDSCO
India's CDSCO operates under the NDCTR 2019 framework with state-level ethics committee coordination across a fragmented institutional landscape. The Digital Personal Data Protection Act (DPDP 2023) adds a data governance layer that international sponsors must navigate.
Celina's CDSCO Blueprint encodes the complete Indian regulatory architecture: NDCTR submission pathways, multi-state ethics committee coordination, DPDP data protection requirements, and ICMR guideline compliance. Three-Gate verification validates your protocol against Indian-specific requirements while maintaining audit-ready traceability.
NexTrial's operational partnership with VeriTrial India provides on-ground deployment across 25 sites — intelligence from Celina, execution on the ground.
“Your protocol was designed for one jurisdiction. Celina validates it for every jurisdiction you need. Risk-based quality by design — applied to market entry.”
You just received a final protocol. You need 15 sites activated across 3 jurisdictions. Your activation target is 45 days. Your team is already assembling regulatory packets manually.
This is the moment you open Celina.
Frequently Asked Questions
How long does it take to deploy TAI for a new trial?
Initial pilot deployment typically takes 4-6 weeks, including protocol configuration, jurisdiction mapping, and site readiness calibration. Subsequent trials on the same jurisdictions activate faster as the Country Blueprints are already encoded.
What does a clinical trial delay cost per day?
Clinical trial activation delays cost sponsors approximately $55,000 per day in direct costs, with enrollment burn rates of $600,000 to $1.2 million per month while sites remain inactive.
How does Celina integrate with our existing CTMS?
Celina integrates via API-first architecture with Veeva, Medidata, and existing CTMS platforms. Plugin boundary: we orchestrate activation workflows, your systems govern storage. No rip-and-replace required.
Does Celina make regulatory decisions?
No. Celina generates audit-ready regulatory packets and validates them against jurisdiction-specific requirements. All regulatory and clinical decisions remain with your team. Human-in-the-loop is architecture, not just governance.
Can TAI support multi-country trial launches?
Yes. TAI supports simultaneous activation across FDA, ANVISA, and CDSCO jurisdictions. One protocol can activate in parallel across the US, Brazil, and India with jurisdiction-specific documentation generated for each.
See how TAI compresses your next trial activation.
Presenting at DIA 2026 · Philadelphia · June 14-18