Global Precision. Local Mastery.
Multi-jurisdiction regulatory intelligence — enabling the same protocol to activate across FDA, ANVISA, and CDSCO in parallel.
The Problem
Sponsors who treat regulatory as a market-by-market afterthought trigger avoidable delays. DDCM/DEEC misalignment. Reliance document errors. CMC data gaps. CEP pendências. Every one of these is preventable. The answer isn't more templates — it's infrastructure.
Predict → Activate → Prove
- •FQG+ scores site readiness across six dimensions: patient access, staff capability, equipment, regulatory compliance posture, historical performance, enrollment velocity.
- •Patient Trajectory Intelligence models eligibility as continuous flows — physics-informed prediction, not binary matching.
- •CFM-1 Regulatory Engine with jurisdiction-specific adapters.
- •Country Blueprints encode 6-12 months of regulatory knowledge per jurisdiction. Each creates an 18-36 month replication barrier.
- •Zero-Rejection Architecture: every packet validated before submission. Deterministic verification — proof certificates, not confidence scores.
- •94% first-submission approval vs. 70-75% industry.
- •Celina sends verified Schedule of Activities and recruitment plans to CTMS/EDC.
- •Reads execution signals back — screening data, enrollment velocity, deviations.
- •Every site's data sharpens the next prediction. The loop never breaks.
Plugin Boundary Covenant
“We will never store a document. We will never capture a data point. This isn't a policy. It's architecture.”
Jurisdiction Map
United States
FDA, IRBs
Brazil
ANVISA, CEP/CONEP
Lei 14.874/2024, RDC 945/2024
India
CDSCO, ICMR, State Ethics
EU
EMA, CTIS
China
NMPA
Mexico
COFEPRIS
Colombia
INVIMA
Argentina
ANMAT
Why Now
FDA AI Guidance (Jan 2025)
Requires 'model credibility.' Black-box AI rejected. Deterministic AI is what regulators want.
ICH E6(R3)
New GCP mandates risk-based quality management. NexTrial's Predict → Activate → Prove operationalizes it.
ANVISA Lei 14.874/2024
Brazil's new law creates an 18-month first-mover window. NexTrial's ANVISA Blueprint is the only platform fully encoded.
Ready to activate across jurisdictions?
See how NexTrial.ai's regulatory intelligence can compress your trial activation timeline and improve first-submission approval rates.