AE Connect handles the intake layer end-to-end: AI-assisted triage, MedDRA coding, E2B narrative generation, and a validated 7-state case workflow. Your PV team can focus on science, not paperwork.
The moment a case enters AE Connect, the AI triage engine runs a full analysis before a human reviewer touches it. Every assessment is auditable and reviewer-editable.
AI maps reported symptoms and events to the correct MedDRA Preferred Term and System Organ Class using the current MedDRA dictionary. Suggestions are presented with confidence indicators. Reviewers confirm, override, or add additional terms directly in the case record.
Automated assessment using WHO-UMC criteria. The engine evaluates temporal relationship, dechallenge/rechallenge data, and alternative explanations to generate an initial causality rating.
Each case is automatically classified as serious or non-serious per ICH E2A criteria and expected or unexpected against the current Reference Safety Information on file.
15-day and 7-day clock alerts are triggered automatically based on seriousness and expectedness classification. Your team sees submission deadlines the moment a case is triaged.
Cases involving potential signals, including disproportionality patterns and cluster events, are flagged for PV team review before entering the submission queue.
The AI generates a structured ICH E2B(R3)-compliant case narrative automatically. Reviewers edit inline and approve. No manual drafting from scratch.
Every case moves through a defined, auditable lifecycle. State transitions are role-gated, timestamped, and logged, satisfying 21 CFR Part 11 and GAMP 5 requirements out of the box.
State changes require the appropriate role. Reporters can submit; only Reviewers and above can approve. Admins can override with a documented reason.
Every action including field edits, state transitions, comments, and attachments is logged with user identity and timestamp. Audit logs are immutable and exportable.
Generate a formatted case summary PDF at any workflow stage. Suitable for regulatory submission packages, sponsor review, and archive.
AE Connect supports 10 languages with full RTL rendering. Reporters in any geography can submit in their native language while your PV team works in English.
Submitted reports in non-English languages are auto-translated into English for PV team review, with the original preserved in the case record.
Arabic and Hebrew intake forms render with proper right-to-left layout, bidirectional text handling, and correct punctuation mirroring.
Generate unique intake URLs per language for distribution to site staff, patients, or HCPs. Each link opens a pre-configured intake form in the correct language.
Six user roles map to real PV team structures, from external reporters to QORO super admins. Permissions are granular, auditable, and configurable per workspace.
AE Connect is validated as GAMP 5 Category 5 by QORO. Clients qualify it as Category 3 (COTS). A complete validation documentation package is included with every account.
12 GxP documents included: URS, TDD, FRS, IQ/OQ Protocol with 70 test cases, RTM, Supplier Qualification Package, Customer Validation Toolkit, Change Control SOP, and Regulatory Compliance Assessment.
All approvals and sign-offs are captured as compliant electronic signatures with user identity, timestamp, and meaning, meeting 21 CFR Part 11 Subpart C requirements.
Hosted on AWS with encrypted data at rest (AES-256) and in transit (TLS 1.3). PostgreSQL on RDS with automated backups, isolated by workspace. SOC 2 audit in planning.
AE Connect integrates with any safety database. Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety remain the system of record. A reviewer accepts or overrides the draft, and the case integrates with that database.
The reviewed draft covers seriousness, a MedDRA suggestion, causality, expectedness, a timeline, and a narrative. AE Connect integrates that case with Argus, LifeSphere, Vault Safety, and other safety databases. Those products remain the system of record.
You can upload a saved email (.eml) along with PDF, Word, text, CSV, or an image. Parsing runs in the browser. There is no separate intake mailbox that creates cases on its own.
AE Connect integrates with Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, and other safety databases. Those products remain the system of record.
AE Connect integrates the case with the safety database. That database remains the system of record for the E2B(R3) file. Read E2B(R3) case preparation.
You create the account with your name, a company email, a password, your company name, and your role. After you verify the email, you are the admin of a new organization. The sandbox is 14 days with unlimited cases.