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GAMP 5 · 21 CFR Part 11 · GVP · GCP validated

Global AI-native eClinical platform.

Genira reduces manual workload and accelerates regulatory submissions globally for pharma, biotech, and CROs.

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PV.appPV.app— ICSR Causality Assessment
JM
Back to Cases
Report steps
Analyze with AI
1Patient info
2Laboratory tests
3Suspect drug
4Adverse reaction
5Medical history
6Additional info
New report US-000122
Drop files or click to upload
AIPlatform
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Regulatory-grade by design

21 CFR Part 11
GAMP 5
GVP
GCP
ISO 9001

Three jobs your eClinical stack must do.

Genira delivers them as one validated, Global AI-native suite — not a bag of bolted-on tools.

1,620% ROI
Modeled over 12 months
2–3 months
Average payback period
24+
Languages supported
99.95%
SLA-backed availability

Three jobs your eClinical stack must do.

Genira delivers them as one validated, Global AI-native suite — not a bag of bolted-on tools.

Drug safety

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 operations

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
Quality & compliance

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.

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.

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.

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.

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.

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.

Interested in a demo?

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