Drug safety

AE Connect is electronic intake and AI triage for adverse event cases.

The intake form is the case screen. A qualified person brings the source, reads the draft, and accepts or overrides every field.

Start 14-day trial See how it works

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.

Intake is the first patient-safety step.

Late or incomplete intake delays everything downstream. Reports still arrive as email, a PDF, or a forwarded message, and the case is already late, or missing the fields the clock depends on, before anyone opens a safety database.

What late intake does

What AE Connect is

Customizable electronic intake plus AI triage. Two uses. It is not a separate patient portal.

Feed the safety database you already run

Send the reviewed case to Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, or another safety database. Works with: Argus, LifeSphere, Vault Safety.

How it works

01

Bring the source

Paste the narrative, or choose a PDF, Word file, email, text file, or image.

02

Read the draft

Seriousness, a suggested MedDRA term, causality, expectedness, and a reporting clock. AI drafts only. Each field has a short reason.

03

Review and file

A qualified person accepts or overrides every field. File the case in the safety database you already run, or keep the ICSR and the E2B(R3) file in AE Connect.

The longer intake note is on the product page. A walkthrough is the demo.

Human sign-off, and the limits

  • AI drafts only. A qualified person accepts or overrides every field.
  • Not a certified connector. AE Connect does not submit or transmit ICSRs. Product names belong to their owners.
  • A product quality complaint is in scope only when the complaint describes an adverse event. This is not a QMS.
  • No DSUR, no IND annual report, and no other aggregate reports.

Data handling is on the trust page.

Who it is for

  • QPPV
  • Drug safety leads
  • Case processors
  • PV operations at biotechs, CROs, and PV providers

Where to go next

See how it works

Book a walkthrough of intake, the draft, and the safety database path.

Learn

Notes on case intake and the reporting clock. The longer series is the blog.

Pipeline

AE Connect is live. PQC Connect and Combined AE/PQC Connect are in development and are not available for purchase.

Questions teams ask, including safety database use, AE and SAE narratives, product quality complaints, and aggregate reports, are on the product page.

Medicines are built to save and improve lives. AE Connect’s mission is to catch adverse drug reactions before it is too late.

The mission note