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AURA Pharmacovigilance Dashboard - AI-powered drug safety case management and adverse event tracking
0s
Avg. Processing
0+
Validation Rules
0 CFR
Part 11 Compliant
0/7
Signal Monitoring

Intelligence

Automate case intake, medical coding, and narrative generation.

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AURA Case Intake - Automated adverse event processing and ICSR management
Case Intake

Intelligence Case Intake

Drop an email or PDF into Aura. Intelligence reads the document, extracts patient information, identifies adverse events, and creates a structured ICSR in seconds.

  • Parse emails and PDFs automatically
  • Extract patient, reporter, and event data
  • Confidence scoring per field
  • 30-second average processing time
AURA MedDRA Coding - AI-powered medical terminology classification for adverse events
MedDRA Coding

Intelligence MedDRA Coding

Type adverse events in plain language. Intelligence instantly suggests the correct MedDRA preferred term with confidence scoring.

  • Natural language to MedDRA coding
  • Seconds per code vs minutes manual
  • Ranked suggestions with confidence
  • Full hierarchy: SOC, HLGT, HLT, PT, LLT
AURA Narrative Generation - Automated clinical narrative writing for safety reports
Narrative Generation

Intelligence Narrative

Automatically generate regulatory-compliant case narratives from structured data. Review, edit, and approve or use as-is.

  • One-click narrative generation
  • ICH E2B compliant language
  • Fact-checked against case data
  • Edit and refine with AI
AURA Bulk Import - Mass adverse event data migration and E2B import capabilities
Bulk Import

Intelligence Import

Migrate from legacy systems or import case backlogs via CSV, Excel with Intelligence-assisted field mapping.

  • CSV/Excel batch import
  • Automatic field mapping
  • Duplicate detection on import
  • Validation and error reporting

Real-Time Collaboration

Work together on cases like you work together on documents.

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A S Who's editing: A S M
Team Presence

Real-Time Team Presence

See who's viewing, who's editing, and resolve conflicts instantly.

  • See who's working on each field
  • Avatar stack shows active users
  • Automatic conflict resolution
  • Field-level presence indicators
DRAFT REVIEW APPROVED 1 2 Case AE-2024-001
Workflows

Workflow & Approvals

Define custom approval workflows that match your SOPs.

  • Custom multi-step approval workflows
  • Auto-assignment based on rules
  • SLA tracking and violation alerts
  • Approval/rejection with comments
Drop files or browse PDF 3 source_doc.pdf Uploaded
Documents

Document Library

Centralized repository for all supporting documents.

  • Drag-and-drop upload
  • Link documents to multiple cases
  • Version control
  • PDF, images, and email attachments
7 NARANJO SCORE Probable 0 5 10 Doubtful Definite
Causality

Causality Assessment

Evaluate drug-event relationships using validated algorithms.

  • Naranjo algorithm scoring
  • WHO-UMC causality categories
  • Global introspection assessment
  • Documented rationale for audits

Signal Detection

Automated safety signal detection. Identify risks before they become crises.

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Threshold PRR ROR χ² IC !
Statistical Analysis

Statistical Analysis

Industry-standard disproportionality analysis running automatically.

  • PRR (Proportional Reporting Ratio)
  • ROR (Reporting Odds Ratio)
  • Chi-square statistical testing
  • Configurable thresholds
Critical Signal Detected 2 warnings pending review
Alerting

Alerting & Reports

Get notified when signals exceed thresholds.

  • Critical signal alerts
  • Daily digest emails
  • Weekly summary reports
  • Custom recipient lists
3 Critical 7 Warning 24 Reviewed
Signal Dashboard

Signal Dashboard

Visual overview of all detected signals with drill-down.

  • Visual PRR/ROR charts
  • Signal status tracking
  • Drill-down to cases
  • Export for PSMF
PRR
Analysis
ROR
Analysis
χ²
Chi-Square
Daily
Analysis

Regulatory Submissions

E2B(R3), CIOMS I, MedWatch 3500A. Validated and ready to submit.

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<?xml?> <icsr> <patient>...</patient> <reaction>...</reaction> <drug>...</drug> </icsr> E2B
E2B(R3) Export

E2B(R3) XML Export

Generate FDA-compliant E2B(R3) XML with one click, ready for gateway upload.

  • ICH E2B(R3) compliant
  • Pre-export validation
  • Download for FDA ESG submission
  • Batch export
CIOMS I FORM PDF
CIOMS & MedWatch

CIOMS I & MedWatch

Generate print-ready PDF forms.

  • CIOMS I PDF generation
  • MedWatch 3500A forms
  • Auto-populated
  • Print-ready
VERIFIED 21 CFR 11 🔒 SHA-256
E-Signatures

Electronic Signatures

21 CFR Part 11 compliant e-signatures.

  • SHA-256 cryptographic hashing
  • Signature with meaning
  • Complete history
  • Tamper detection
Case submitted 2m ago Status → Review 5m ago MedDRA-aligned 8m ago Case created 1h ago
Audit Trail

Complete Audit Trails

Every action logged. FDA inspection-ready.

  • User, timestamp, IP logging
  • Old/new value tracking
  • Change reason documentation
  • Visual timeline
E2B(R3)CIOMS IMedWatch 3500A21 CFR Part 11ICH E2BICH E2D

Your Platform, Your Way

Start with Core PV. Add Intelligence when you're ready.

One Platform, Many Sponsors

  • Complete data isolation between tenants
  • Shared infrastructure, separate databases
  • Tenant-specific branding and configuration
  • Cross-tenant reporting for CROs
AURA Pharma A Biotech B CRO C

Enable Anytime

  • Toggle Intelligence on/off per user
  • Gradual rollout to your team
  • No workflow disruption
  • Instant activation, no setup
OFF ON INTELLIGENCE
247 Open Cases 98% Compliance 12 Due Today CASE ID STATUS DUE PRIORITY AE-2024-001 Dec 24 AE-2024-002 Dec 26 AE-2024-003 Dec 28 AE-2024-004 Dec 30

Complete Pharmacovigilance

Start with Core
  • Complete ICSR lifecycle management
  • E2B(R3), CIOMS I, MedWatch exports
  • 21 CFR Part 11 compliant audit trails
  • Electronic signatures with SHA-256
  • Configurable workflows and approvals
  • Signal detection and analysis
AI MedDRA Narrative Signals 30s Processing 40+ Rules Daily Analysis

Automation That Works

Add Intelligence
  • Auto-parse emails and PDFs
  • Natural language MedDRA coding
  • One-click narrative generation
  • Smart field mapping on import
  • Duplicate case detection
  • Compliance suggestions

Simple Pricing

No implementation fees. No six-month deployments. Start today.

Starter

$8K /year

Core PV for early-stage teams

  • 3 users
  • 250 cases/year
  • E2B + CIOMS + MedWatch
  • MedDRA-aligned coding
  • 21 CFR Part 11 audit trail
  • Email support

Growth

$12K /year

Scaling teams

  • 10 users
  • 1,000 cases/year
  • Intelligence AI document import
  • QC reviewer workflow
  • Real-time collaboration
  • Priority support

Professional

$25K /year

Intelligence-powered

  • 25 users
  • 5,000 cases/year
  • Intelligence signal detection
  • Quality management (CAPAs, deviations)
  • IP & session controls
  • Phone/video support

Enterprise

Custom

Global operations

  • Unlimited users & cases
  • Intelligence narrative generation
  • Product complaints + training
  • Custom branding
  • Dedicated CSM
Contact Sales
Intelligence

Stop copying.
Start approving.

Drop a document. Get a structured case. The tedious work of reading emails, extracting data, and coding terms—gone.

Instant Intake

Emails and PDFs—drop them in. AI reads, extracts, and structures in seconds.

Smart Coding

Type plain English. Get ranked MedDRA suggestions with confidence scores.

One-Click Narratives

Regulatory-compliant narratives generated automatically. Review and approve.

30s
Avg Processing
40+
Validation Rules
Daily
Signal Analysis
Collaboration

Your team.
Same case. Same time.

No more email chains. No version conflicts. No "who touched this last?" See everyone working, live.

Real-Time Presence

See who's viewing each case and field. Coordinate work without conflicts.

Instant Sync

Changes appear everywhere, immediately. One source of truth.

Full Audit Trail

Every change tracked. Every user logged. Complete accountability built in.

0
Email Attachments
1
Version of Truth
100%
Audit Coverage
Signal Detection

Find it
before it finds you.

Proactive safety monitoring. Automated signal detection with daily analysis runs.

Early Warning

Detect emerging signals before they become crises. Act early, not reactively.

Automated Analytics

PRR, ROR, Chi-Square calculations running continuously. No spreadsheets required.

Instant Alerts

Threshold breached? Get notified immediately. Never miss a critical signal.

Daily
Analysis
PRR/ROR
Statistics
4
Severity Levels
Regulatory

One click.
Export ready.

E2B(R3), CIOMS I, MedWatch 3500A. Generate validated files ready for submission.

Validated Output

Every field checked. Every format verified. Submit with confidence.

Meet Every Deadline

Expedited, periodic, or follow-up. Track timelines automatically.

FDA Ready

FDA E2B(R3) compliant. Export validated XML for ESG submission.

E2B R3
Compliant
Global
ICH Compatible
1-Click
Export