Local-First Semantic Compilation Architecture
Automate unstructured clinical trial protocol conversion into production-ready EDC structures with absolute data sovereignty, hardware-grounded verification gates, and 100% mathematical bounding-box traceability.
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
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 (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.
Sovereign Hardware Appliance Fleet
To deliver complete air-gapped data sovereignty and zero cloud egress during clinical trial compilation, G-Flow delivers dedicated on-premise hardware appliances powered by local Blackwell and Ada micro-architectures. The Makoto Tiger™ micro-workstation is available today, procured exclusively via our authorized Dell OEM partner channel:
Makoto Ocelot™
Single-node workstation engineered for academic medical centers, phase 1 PK/PD units, and animal health studies.
- Chassis: Dell Precision 5860 Tower
- GPU: 1x NVIDIA RTX 5000 Ada Generation (32GB GDDR6 ECC VRAM)
- Compute: Intel Xeon W-Class, 128GB DDR5 ECC RAM
- Model Profile: Dual Concurrent Gemma 12B FP8 Models (Inference + Judge)
Makoto Tiger™
Compact micro-workstation engineered for single-team pharma sponsors and growing mid-market CROs. Available today for enterprise deployment.
- Chassis: 1x Dell Pro Max GB10 Micro-workstation
- GPU / VRAM: Single Blackwell GPU, 128GB Unified Blackwell VRAM
- Safety Interlock: Physical execution halt signal bus circuitry
- Model Profile: Gemma 4 26B Specialist + Gemma 4 31B Judge (uncompressed)
- Procurement: $7,000 via Dell OEM partner portal (exclusive • third-party retail not supported)
Makoto Jaguar™
Dual-node high-availability cluster built for enterprise CROs running 15+ concurrent clinical trial builds.
- Chassis: 2x Dell Pro Max GB10 Micro-workstations
- GPU / Interconnect: Dual Blackwell GPUs, 256GB Unified VRAM, NVLink
- High Availability: Active-Active failover & zero-downtime state migration
- Model Profile: Distributed Gemma 4 MoE Specialist + 31B Judge
Makoto Cheetah™
Quad-node flagship enterprise mega-cluster engineered for Global Top-20 Pharma (40+ concurrent trials).
- Chassis: 4x Dell Pro Max GB10 Quad Cluster
- GPU / Interconnect: 8x Blackwell GPUs, 512GB Unified VRAM, NVLink
- Acceleration: vLLM Tensor Parallelism + 4-Persona Consensus acceleration
- Deployment: Dell OEM white-glove rack installation & 4-hour on-site SLA