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$100B Market Impact.** Automating pharma compliance to capture a $20B TAM. A 2M context provides a competitive edge.
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**$100B Market Impact:** Transforming 12 months of manual review into minutes of autonomous intelligence.
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**Enterprise-Ready Interface.** Secure, scalable access for biotech and legal teams to manage regulatory intelligence.
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**Secure Enterprise Portal.** Professional login system designed for high-security medical-legal environments.
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**One-Click Upload.** Ingesting 500+ page protocols for rapid autonomous analysis.
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**Multi-Type Data Support.** Advanced parsing for clinical protocols and regulatory files with zero data loss.
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**High-Speed Ingestion.** Processing heavy clinical PDFs in seconds using Gemini's 2M token context window.
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**Agentic Workflow Architecture.** Multi-agent orchestration using LangGraph and Gemini for autonomous, traceable reasoning.
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**Start Analysis.** Initiating autonomous risk detection for 500+ page clinical trial protocols.
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**Targeted AI Analysis:** Selecting specific regulatory frameworks like FDA/EMA for precise, autonomous risk assessment.
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**System Performance Tracking:** Real-time monitoring of autonomous reasoning tasks and execution speed.
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**Audit-Ready Insights:** Automated summary detecting critical review areas and compliance enhancement recommendations.
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**Compliance Intelligence Dashboard:** Real-time scoring, automated risk flagging, and executive summaries for clinical trials.
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**Actionable Risk Analysis:** Detailed compliance flagging with precise document locations and automated remediation steps.
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**Deep Compliance Intelligence:** Autonomous detection of missing clinical disclosures with specific remediation advice.
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**Audit-Ready Exports:** Generating professional compliance reports tailored for FDA, EMA, and ICH global standards.
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**Final Audit Report:** Complete executive summary and report metadata generated by multi-agent reasoning.
OMNY-ANALYST: Autonomous Regulatory Intelligence for Biotech
"Transforming 500+ page clinical protocols into audit-ready decisions in minutes — not months."
BUSINESS IMPACT
- The Problem: Clinical trials are delayed by 12 months due to manual review.
- The Cost: Companies lose billions in potential revenue.
- The Solution: OMNI-ANALYST automates the $100B bottleneck of medical-legal compliance.
CORE CAPABILITIES
- Gemini 2.0 Power: Ingests 500+ page protocols in one step (2M token context).
- Agentic Reasoning: Multi-agent system that reasons like a regulatory expert.
- Zero-Error Focus: Automated risk flagging with Audit-Ready reports.
TECH STACK
| LAYER | TECHNOLOGY |
|---|---|
| Reasoning Core | Google Gemini 2.0 Flash |
| Orchestration | LangGraph / LangChain |
| Integrations | FastAPI, Supabase, Bolt.new |
WHY WE WIN
- NOT A CHATBOT: It's a structured reasoning engine.
- GROUNDED: 0% Hallucinations via retrieval-constrained generation.
- SCALABLE: Enterprise-grade architecture ready for Big Pharma.
[https://drive.google.com/file/d/1bQIpq4b4V0yFIVUPEq8USdj2bKiSodiI/view)
Built With
- bolt.new
- gemini-2.0-flash
- react
- supabase
- tailwind-css
- typescript
- vite
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