The AI Orchestration Layer for Clinical Trial Activation
Compress trial activation from 120 days to 30-45. Reconstructable by design. Rule sets encoded and live for FDA, ANVISA, and CDSCO.
The Activation Bottleneck Costs $37,000–55,000 Per Day
Average time to First Patient In
First-submission regulatory rejections
Phase III direct costs
The bottleneck isn't science — it's activation. Email threads, manual readiness checks, non-predictive feasibility, and zero explainability for regulators. There is no activation infrastructure. We're building it.
Protocol In → Readiness Out
Protocol Intelligence
Celina parses protocols into structured regulatory requirements
Regulatory Orchestration
Jurisdiction-specific compliance: FDA, ANVISA, CDSCO
Site Readiness
Predictive scoring validates site capability before activation
Activation
Packets assembled, lineage preserved, every output reconstructable
Proven. Not Promised.
days
Trial activation compression demonstrated in pilot
First-submission approval rate
3 Jurisdictions
FDA · ANVISA · CDSCO
The only platform with multi-jurisdiction regulatory intelligence
Built for How You Work
For Sponsors
Clinical Operations
Your trials are burning $37K–55K/day waiting for activation
Predictable First Patient In across every jurisdiction
See Sponsor SolutionsFor CROs
Director of Operations
Activation delays erode 15% of your gross margin per trial
White-label activation intelligence that protects your margin
See CRO SolutionsFor Sites & Networks
Site Coordinators
25-30% of regulatory submissions are rejected on first attempt
First-pass ready packets, +7.5 hours/week back for coordinators
See Site SolutionsOrchestration Intelligence. Not Another Dashboard.
What Others Build
- Dashboards that report delays
- Confidence scores
- Regional point solutions
- Manual document assembly
- Retrospective analytics
What Celina Provides
- Intelligence that prevents them
- Formal validation, uncorrelated evidence
- Multi-jurisdiction regulatory engine
- Packet assembly with a reconstructable record
- Predictive activation timelines
Celina orchestrates. Humans decide. Patients get access.
Presented at DIA 2026 · Philadelphia · June 2026 · Abstract 116114