Платформа eClinical на базе ИИ.
Genira сокращает ручной труд и ускоряет регуляторные субмиссии по всему миру для фармацевтики, биотехнологий и CRO.
PV.app— ICSR Causality Assessment
PlatformRegulatory-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.
AI-driven pharmacovigilance with automated MedDRA coding, ICSR/PSUR/DSUR generation, and direct gateway submissions to FDA, EMA, MHRA.
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
Создано для реальной регуляторной работы.
Мобильный прием данных, офлайн-режим и прямые субмиссии во все крупные регуляторные органы.
Interested in a demo?
Leave your details and a product specialist will reach out within one business day.