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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

Phone, tablet, or desktop — one validated experience.

Offline reporting

Capture anywhere. Sync when connected.

Regulatory submissions

Direct gateway to FDA, EMA, and 6 more.

Validation matters

GAMP 5 Cat 4 out of the box.

Smart notifications

Role-aware alerts that keep teams aligned.

Auto coding

MedDRA & WHODrug with confidence scores.

Inline hints

Regulatory guidance right where you need it.

Multidevice support

Phone, tablet, or desktop — one validated experience.

Offline reporting

Capture anywhere. Sync when connected.

Regulatory submissions

Direct gateway to FDA, EMA, and 6 more.

Validation matters

GAMP 5 Cat 4 out of the box.

Smart notifications

Role-aware alerts that keep teams aligned.

Auto coding

MedDRA & WHODrug with confidence scores.

Inline hints

Regulatory guidance right where you need it.

Multidevice support

Phone, tablet, or desktop — one validated experience.

Offline reporting

Capture anywhere. Sync when connected.

Regulatory submissions

Direct gateway to FDA, EMA, and 6 more.

Validation matters

GAMP 5 Cat 4 out of the box.

Smart notifications

Role-aware alerts that keep teams aligned.

Auto coding

MedDRA & WHODrug with confidence scores.

Inline hints

Regulatory guidance right where you need it.

Interested in a demo?

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