TECHNICAL SPECIFICATIONS

Local-First Semantic Compilation Architecture

Automate unstructured clinical trial protocol conversion into production-ready EDC structures with absolute data sovereignty and mathematical grounding.

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Data Sovereignty (Local-First)

Runs entirely on local node appliances using localized inference hardware. Secure your trial IP inside your firewall.

  • Behind private physical enterprise firewalls
  • Local vLLM inference engine (Gemma 4 models)
  • Zero cloud APIs or third-party LLM dependencies
  • Bypasses multi-month SaaS InfoSec audits

GxP & CDISC Automation

Ingest protocol PDFs and compile variables directly to regulatory CDISC schemas and EDC structures.

  • Strict compliance with CDASH v1.3 standards
  • Automatic compilation to SDTM structures
  • Universal Medidata Rave ALS & SDM-XML export
  • No manual database programming needed
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Universal Vendor Agnosticism

Compile once in standard CDISC IL and deploy targeting any EDC system without rebuilding eCRFs from scratch.

  • Target Medidata Rave ALS, Veeva CDMS, Oracle
  • Open CDISC ODM-XML & CDASH IL representation
  • Zero proprietary vendor format lock-in
  • Instant cross-EDC protocol portability

Competitor Technology Matrix

Compare G-Flow's local-first compiler architecture against manual SaaS form builder setups.

Architectural Capability Medidata Rave (Manual Programming) Veeva Vault CDMS (Standard Setup) Oracle Clinical One (Legacy Pipeline)
G-Flow G-Flow (Makoto Architecture)
AI Integration & Engine Medidata Designer (Cloud-based AI/ML assistant for CRF mapping) Veeva CDB (Post-hoc AI query automation; no design automation) Life Sciences AI Data Platform (Post-hoc analytics and mapping) Local-First LLM Ingestion (Real-time schema translation & build)
Ingestion Pipeline Manual specifications entry Drag-and-drop UI manual mapping Manual database scripting Automated LLM semantic parsing
Typical Build Timeline 12 to 17 Weeks 10 to 14 Weeks 14 to 18+ Weeks < 24 Hours (Protocol to production ALS)
InfoSec & Data Sovereignty SaaS Cloud (Requires third-party validation) SaaS Cloud (InfoSec audit bottlenecks) Multi-tenant cloud or hosting 100% Local-First (Behind private firewall)
CDISC Alignment Post-hoc manual mapping checks Manual library mapping Database level script checks Automated CDASH v1.3 compilation
Execution Sign-off Fragmented email approvals Digital signatures post-build Custom manual QA gate checklists Strict 4-Expert consensus Scrum Gate
Output Interoperability Target database execution only Locked to Veeva ecosystem Legacy Oracle formats 100% Universal (Rave ALS, Veeva CDMS, ODM-XML)
Vendor Lock-In Risk High (Locked to Medidata Cloud) High (Locked to Veeva Suite) High (Locked to Clinical One) Zero (Vendor-Agnostic CDISC IL Portability)

💡 Evaluating specialized or mid-market EDCs? Explore our Mid-Market Alternatives & Portability Index to see how G-Flow compares to Viedoc, Castor EDC, Medrio, and ClinCapture.

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