Global 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.
Live ICSR flow across regulatory hubs
Regulatory-grade by design.
Three jobs your eClinical stack must do.
Genira delivers them as one validated, Global 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.
Multidevice support
Patients, sites, and reviewers work from phone, tablet, or desktop with the same validated experience.
Offline reporting
Capture cases in remote sites or low-connectivity regions; sync and reconcile when back online.
Regulatory submissions
Direct gateway submissions to FDA, EMA, MHRA, PMDA, NMPA, ANVISA, HSA, and Health Canada.
Validation matters
Every release ships with a GAMP 5 Cat 4 validation package — URS, FS, IQ/OQ/PQ, traceability.
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 Global 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.
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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