AE Connect handles intake, MedDRA coding, causality assessment, and FDA filing — so your drug safety team can focus on science, not paperwork.
Your first approved product means you're legally obligated to report adverse events — forever. Most lean teams are drowning in manual processes that cost a fortune and create compliance risk.
Manual intake, MedDRA lookup, narrative writing, and E2B formatting takes 3–5 hours per case. With 500+ cases a year, that's entire headcount consumed by data entry.
$131K+ in annual labor per 500 casesExpedited reports must reach the FDA within 15 calendar days of awareness. Manual tracking fails at scale — and late filings mean Warning Letters.
FDA enforcement on the riseArgus, Veeva Vault Safety, and similar platforms cost $80K–$250K+ annually — built for Big Pharma, priced out of reach for emerging biotech.
AE Connect costs up to 75% lessAE Connect handles the full adverse event lifecycle — from the moment a reporter submits to the moment the E2B file lands at the FDA.
HCPs, patients, and literature sources submit via a branded, configurable intake form. No phone tag. No fax.
Smart form validationClaude AI instantly suggests MedDRA coding, seriousness criteria, expectedness, and causality assessment.
MedDRA v27 dictionaryYour team reviews AI suggestions, edits the narrative, and approves the case — in a fraction of the normal time.
Full audit trailOne-click E2B XML export and direct MedWatch submission. 15-day deadlines tracked automatically.
FDA & EMA readyNo bloat. No features built for 500-person PV departments. AE Connect is built for lean teams that need to move fast and stay compliant.
Claude AI reads every incoming case and suggests MedDRA PT/SOC/LLT codes, causality assessment using WHO-UMC criteria, seriousness, and regulatory reporting recommendation — before your team touches it.
A branded, validated reporter intake form that captures all ICH E2B(R3) required fields — adaptable for HCP, patient, and literature reports.
Every case gets an automatic clock. 15-day expedited, 7-day fatal/life-threatening, and periodic report deadlines tracked and escalated automatically.
One-click generation of ICH E2B(R3) XML files for FDA and EMA submission. Direct MedWatch integration. No manual data re-entry.
Complete electronic audit trail with timestamps, user attribution, and change history on every case action. Supports your CSV process with IQ/OQ documentation on Scale+.
No per-seat pricing. Drug Safety Associates, Medical Directors, QA reviewers — all with appropriate access controls. Five-tier RBAC with admin dashboard.
AE Connect is designed from the ground up for 21 CFR Part 11 and ICH E2B compliance. Not bolted on after the fact.
Book a 20-minute discovery call. No deck, no pressure — just an honest conversation about your PV program and whether AE Connect is the right fit.