Every phase of the trial.
One intelligent platform.
From protocol authoring to regulatory submission — medinovAI replaces the 7.3-system fragmentation that defines traditional clinical operations with a single AI-native intelligence layer.
20 Integrated Clinical Systems
Every module shares the same data, auth, and audit infrastructure — eliminating reconciliation overhead.
eTMF — Electronic Trial Master File
AI-powered document classification with 98.7% completeness scoring. Real-time inspection readiness dashboard. DIA TMF Reference Model compliant. Automated artifact routing and approval workflows.
- 98.7% TMF completeness
- Real-time inspection readiness
- DIA Reference Model compliant
CTMS — Clinical Trial Management System
Protocol-driven site management, enrollment tracking, and milestone monitoring. Predictive enrollment modeling at 94% accuracy. Automated protocol deviation detection.
- 94% enrollment prediction accuracy
- Protocol deviation auto-detection
- Site performance benchmarking
EDC — Electronic Data Capture
Zero-transcription data entry via EHR integration. Real-time discrepancy detection. CDISC ODM-compliant. Auto-maps EHR data to eCRFs eliminating manual transcription.
- Zero manual transcription
- Real-time discrepancy detection
- CDISC ODM compliant
Safety & Pharmacovigilance
Sub-5ms adverse event detection. 97.3% MedDRA coding accuracy. Automated SUSAR generation in under 2 hours. Signal detection across 200+ clinical data streams simultaneously.
- 97.3% MedDRA accuracy
- SUSAR in <2 hours
- 200+ signal streams
Regulatory Submission
Protocol → CDISC → eCTD → FDA ESG → Global. Parallel filing to EMA, PMDA, TGA, Health Canada. 12,000+ CDISC validation rules automated. Direct FDA ESG submission capability.
- Direct FDA ESG submission
- Parallel global filing
- 12,000+ validation rules
LIS — Laboratory Information System
RFID chain-of-custody from collection to result. 99.6% pre-analytic specimen integrity. Sub-60-second IoT thermal excursion alerting. CAP Q-PROBES quality standards.
- 99.6% specimen integrity
- RFID chain-of-custody
- IoT thermal monitoring
End-to-End Trial Workflow
Protocol Authoring
AI-assisted protocol development with regulatory template library and feasibility scoring
Site Selection
Predictive site performance modeling. Automated feasibility questionnaires. IRB/EC tracking
Patient Recruitment
EHR-based pre-screening. myOnsite DCT visits. 34% screen failure reduction
Data Collection
Zero-transcription EDC. ePRO/eDiary. RTSM. Real-time monitoring
Safety Monitoring
Continuous AE surveillance. Automated MedDRA coding. DSMB dashboards
Regulatory Submission
CDISC automation. eCTD assembly. FDA ESG + parallel global filing