AE Connect

AE Connect is a safety intake product developed by QORO Intelligence, designed to capture adverse event (AE) reports through a structured, guided form and deliver AI-triaged, coded cases directly into existing safety databases such as Veeva Vault Safety and Oracle Argus. It is aimed at biotech companies — particularly pre-commercial and small biotechs — that need a structured intake and triage layer without replacing their entire pharmacovigilance (PV) infrastructure.

The product addresses a common gap in PV workflows: AE reports arrive through disconnected channels (email, phone, paper forms, web portals), requiring manual rekeying into safety databases. AE Connect replaces that manual step with a structured intake pipeline that feeds coded, triaged cases directly into the safety system of record, with a human review gate before any data is submitted.

Core Problems Addressed

• Manual rekeying of intake data into safety databases accounts for over 60% of case processing time and introduces transcription errors.
• Disconnected intake channels — email, phone, web forms — do not feed directly into Veeva Vault Safety, Argus, or other ICSR systems, creating compliance risk.
• Unstructured intake leads to incomplete cases, missing fields, and free-text entries where coded terms are required, resulting in follow-up burden for PV teams.
• Enterprise safety suites cost $500K or more and take 12 or more months to implement, making them inaccessible for smaller or pre-commercial biotechs.

Intake Form Features

• A 5-step guided reporter form covering patient details, product information, event description, reporter identity, and a confirmation/review step, with progress tracking and field validation at each stage.
• Multi-channel capture: public web portal, internal forms for healthcare professionals (HCPs) and field teams, and email-to-case ingestion, all feeding into the same structured pipeline.
• Configurable per organization: custom branding, product lists, field requirements, consent language, and a dedicated intake URL for each organization.
• Mobile-first, responsive design supporting submission from any device, with offline-capable draft saving for reporters in the field.
• HIPAA-ready data handling, consent capture, audit trails on every submission, and 21 CFR Part 11 electronic signature support.
• Instant AI triage triggered at the moment of submission: auto-coding of MedDRA terms, seriousness and causality assessment, and flagging of cases requiring immediate attention.

AI-Powered Triage Capabilities

• MedDRA auto-coding maps free-text event descriptions to MedDRA Preferred Terms and Lowest Level Terms, with multiple candidates ranked by confidence.
• Causality assessment evaluates temporal relationship, dechallenge/rechallenge data, and known drug profile to generate a preliminary causality determination.
• Seriousness classification follows ICH E2D guidelines and automatically flags cases requiring expedited reporting (15-day and 7-day timelines).
• Structured case narrative drafting from submitted data, ready for PV team review and inclusion in the ICSR.

Integration Architecture

• Direct API integration with Veeva Vault Safety: cases flow into the Vault inbox as structured ICSRs with MedDRA coding intact.
• Oracle Argus Safety integration via E2B(R3) XML or direct API, with mapped fields, coded terms, and seriousness assessments transferred automatically.
• ICH-compliant E2B(R3) XML export for any safety database or direct regulatory submission to FDA MedWatch and EudraVigilance.
• Open REST API (coming soon) for integrating with safety databases not listed above.
• Data transferred includes patient demographics, medical history, concomitant medications, AI-coded MedDRA terms, seriousness and causality assessments, product information with suspect/concomitant classification, reporter details, narrative text, and supporting documents.
• One-way data push: AE Connect sends data to the safety database, which remains the system of record.
• Field mapping is configurable per organization and safety database; transmission is encrypted with a full audit trail.
• A manual review gate is in place before any case is submitted to the safety database.
• Retry logic and error handling for failed transmissions, with admin alerts.

Workflow Steps

1. Reporter (HCP, patient, or field rep) completes the guided 5-step intake form via web portal, mobile, or internal submission.
2. AI engine auto-codes MedDRA terms, assesses seriousness and expectedness, runs causality analysis, and flags priority cases.
3. PV specialist reviews the AI analysis, confirms or adjusts coding, and approves the case for submission.
4. Approved cases push directly into Veeva Vault Safety, Oracle Argus, or via E2B(R3) XML, fully structured and audit-trailed.

Product Roadmap

• April 2026 — Private Beta: Guided 5-step intake form, AI-powered MedDRA coding and causality assessment, case management dashboard, Veeva and Argus integration, and role-based access control (RBAC).
• October 2026 — General Availability: Enterprise SLAs, GAMP 5 validation package, E2B(R3) XML export, multi-region deployment, advanced analytics, and open REST API for custom integrations.
• April 2027 — PQC Connect: A separate product for product quality complaints, covering structured complaint intake, investigation workflows, CAPA tracking, and cross-linking with AE Connect for cases involving both safety and quality events.

AE Connect is positioned as an intake and triage layer that complements rather than replaces existing safety infrastructure. It is currently in private beta as of April 2026, with general availability planned for October 2026. The platform is built with compliance requirements in mind, including HIPAA, 21 CFR Part 11, and ICH E2D guidelines, and a GAMP 5 validation package is planned for the general availability release.