AI-native eClinical platform.
Validated by design.
Genira reduces manual workload and accelerates regulatory submissions globally for pharma, biotech, and CROs.
Trusted by safety, quality, and clinical operations teams worldwide.
Regulatory-grade by design.
Three jobs your eClinical stack must do.
Genira delivers them as one validated, AI-native suite — not a bag of bolted-on tools.
Safety reporting made easy.
Medical liaisons, doctors, pharmacists, patients & caregivers send safety reports directly to pharma and regulators — coded, deduped, and submitted by AI.
- From paper forms to a validated cloud workflow
- Works with all major PV databases
- ICH E2B(R3), MedDRA & WHODrug native
Clinical data, end to end.
Cost-effective EDC + ePRO for decentralized and hybrid trials. Collect data directly from patients, validated in real time, with budget control wired in.
- Unified ePRO-to-EDC data flow
- Real-time edit checks and medical coding
- Trial budget & burn rate in one console
Switch to quality.
Save time and resources. Provide clean, validated data. Work in your own templates and stay compliant — across documents, training, CAPA, and audits.
- AI-assisted SOP & document drafting
- 21 CFR Part 11 audit trail out of the box
- External signing without account creation
Built for how regulatory work actually happens.
Mobile-first capture, offline-ready intake, and direct gateway submissions to every major authority.
The details that compound.
Small interactions add up to weeks saved per quarter.
Activity & feedback notifications
Reviewers, sponsors, and CROs stay aligned with role-aware notifications, escalations, and SLA timers.
MedDRA & WHODrug dictionaries
Automatic medical and drug coding with confidence scoring, override, and full lineage for audit.
Embedded hint system
Inline regulatory guidance and protocol hints — so reviewers don't context-switch to find the right rule.
One AI-native suite. Five validated platforms.
Pharmacovigilance, clinical data capture, quality, medical info, and trial budgeting — built to interoperate, validated to ship.
PV.app
All-in-one safety platform
AI-driven pharmacovigilance with automated MedDRA coding, ICSR/PSUR/DSUR generation, and direct gateway submissions to FDA, EMA, MHRA.
eQMS
Stay compliant
AI-powered quality management: document control, CAPA, eLMS, risk matrix, and external signing — deployed in days, not quarters.
EDC + ePRO
Convenient eCRF collection
Unified electronic data capture and patient-reported outcomes with real-time validation, MedDRA/WHODrug coding, and PV integration.
MICC
Medical Information Call Center
Omnichannel medical information with AI copilot, speech-to-text, automatic adverse event capture, and direct PV handoff.
Budgets
Clinical trial budgeting & control
Validated, 21 CFR Part 11–compliant clinical trial budgeting, forecasting, and real-time cost control — wired to EDC, CTMS, and PV.
AI Governance Hub
Explainable AI for medical coding & adverse event classification
The control plane for every AI decision in your safety and clinical workflow — explainable, validated, audit-ready.
Interested in a demo?
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