AE Connect captures adverse event reports through a guided intake form, uses AI to code and triage each case, and sends structured data directly into Veeva, Argus, or your existing safety system, no rekeying, no delays.
Reporters submit AEs through emails, phone calls, paper forms, and portals that don't talk to each other. PV teams manually retype everything into Argus or Veeva. The result? Delays, errors, and regulatory risk.
Safety teams spend the majority of their time transcribing data from intake forms into safety databases rather than evaluating the actual adverse event. Every manual entry is a chance for error.
Most biotechs capture AE reports through disconnected channels, email, phone, web forms, none of which feed directly into Veeva Vault Safety, Argus, or other ICSR systems. The data gap is where compliance risk lives.
Without a structured, guided intake, reporters skip fields, use free text where codes belong, and omit critical details. PV teams chase follow-ups instead of processing cases.
Enterprise safety suites cost $500K+ and take 12+ months to implement. Pre-commercial and small biotechs need the intake and triage layer without replacing their entire safety stack.
AE Connect walks reporters through a structured intake, patient info, product details, event description, reporter information, and review, so every submission arrives ready for triage.
Patient details, product info, event description, reporter identity, and confirmation, with progress tracking and field validation at every step.
Public web portal, internal forms for HCPs and field teams, and email-to-case ingestion, all feeding into the same structured pipeline.
Custom branding, product lists, field requirements, and consent language. Each organization gets its own intake URL and form configuration.
Reporters in the field, HCPs, patients, sales reps, can submit from any device. Responsive design with offline-capable draft saving.
HIPAA-ready data handling, consent capture, audit trails on every submission, and 21 CFR Part 11 electronic signature support.
The moment a report is submitted, AI auto-codes MedDRA terms, assesses seriousness and causality, and flags cases that need immediate attention.
AE Connect isn't a replacement for your safety system, it's the intelligent intake layer that feeds structured, AI-triaged cases directly into Veeva Vault Safety, Oracle Argus, and other ICSR databases. No rekeying. No copy-paste.
Direct API integration with Vault Safety. Cases flow from AE Connect into your Vault inbox as structured ICSRs with MedDRA coding intact.
INTEGRATION READYSubmit triaged cases to Argus via E2B(R3) XML or direct API. Mapped fields, coded terms, and seriousness assessments transfer automatically.
INTEGRATION READYGenerate ICH-compliant E2B(R3) XML for any safety database or direct regulatory submission to FDA MedWatch and EudraVigilance.
BETAFor safety databases not listed here, use our documented REST API to pull structured case data into any system your team uses.
COMING SOONEvery field captured in the intake form and enriched by AI triage flows into your safety database as structured data:
AE Connect is designed to complement, not replace, your existing safety infrastructure:
AE Connect automates the journey from initial adverse event report to structured ICSR in your safety database, with AI assistance and human oversight at every step.
HCPs, patients, or field reps complete the guided 5-step intake form via web portal, mobile, or internal submission.
AI engine auto-codes MedDRA terms, assesses seriousness and expectedness, runs causality analysis, and flags priority cases.
Your safety team reviews the AI analysis, confirms or adjusts coding, and approves the case for submission to your safety database.
Approved cases push directly into Veeva Vault Safety, Oracle Argus, or via E2B(R3) XML, fully structured and audit-trailed.
AE Connect's triage engine is purpose-built for drug safety, not a generic chatbot. It reads narrative text, identifies adverse events, codes to MedDRA, and assesses causality using the same frameworks your PV team uses.
Maps free-text event descriptions to MedDRA Preferred Terms and Lowest Level Terms. Suggests multiple candidates ranked by confidence.
Evaluates temporal relationship, dechallenge/rechallenge, and known drug profile to generate a preliminary causality determination.
Classifies seriousness criteria per ICH E2D guidelines and flags expedited reporting cases (15-day, 7-day) automatically.
Drafts a structured case narrative from the submitted data, ready for your team to review, edit, and include in the ICSR.
AE Connect is our first product, purpose-built for adverse event intake and triage. Next: product quality complaints.
Guided 5-step intake form, AI-powered MedDRA coding and causality assessment, case management dashboard, and Veeva/Argus integration.
Enterprise SLAs, GAMP 5 validation package, E2B(R3) XML export, multi-region deployment, advanced analytics, and open REST API for custom integrations.
Structured complaint intake, investigation workflows, CAPA tracking, and cross-linking with AE Connect for cases that involve both safety and quality events.
Join the private beta and see how AE Connect captures, triages, and delivers structured cases directly into Veeva or Argus.