Home / Product

Email is a bad place to start an adverse-event case.

AE Connect is customizable electronic intake plus AI triage. It can feed the safety database you already run, or it can be the safety database for the full ICSR and the E2B(R3) file. A reviewer accepts or overrides the draft.

This is the longer product note. The home page is the short overview: what AE Connect is, who it is for, and where to go next.

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.

AE, SAE, and SUSAR triage

The draft calls out seriousness and expectedness so a qualified reviewer can decide what is an SAE or a SUSAR. The call stays with the reviewer.

E2B(R3) export

The case is a full ICSR: coding, causality, expectedness, timeline, and an E2B(R3) file. Feed the safety database you already run, or keep the file in AE Connect. See the submission checklist and the E2B(R3) guide.

Human sign-off

Files are read in the browser. Only the extracted text is assessed. You keep the audit trail of what the draft said and what you accepted.

PV case intake, without standing up a safety database first

Bring the source

The intake form is the case screen. Paste the narrative or choose a PDF, Word file, email, text file, or image. Scanned pages can be read with OCR in the browser, and that engine loads only after you choose a file.

Read the draft

You get a structured adverse event assessment: seriousness, a suggested MedDRA term, WHO-UMC causality, expectedness, and a reporting clock. Each field has a short reason.

Review, then file the case

Accept or override the draft. Send the case into the safety database you already run, or keep the ICSR and the E2B(R3) file in AE Connect.

Argus, Safety One, and Veeva Vault Safety

AE Connect can feed Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, or another safety database. It can also be the safety database for the full ICSR and the E2B(R3) file. A reviewer accepts or overrides the draft.

The tables are Argus, LifeSphere, and Vault Safety. The inbox those cases still arrive in is described in the drug safety inbox.

A product quality complaint that describes an adverse event can go through the same intake. PQC reporting as a quality system (complaints, batches, returns) is a different job. Aggregate reports, including the IND annual report and a DSUR, are not produced here. The first-IND PV plan note covers the company core data sheet, expectedness, and those aggregate duties.

Questions teams ask

Does AE Connect integrate the case with a safety database?

Yes. AE Connect can feed any safety database, including Oracle Argus, ArisGlobal LifeSphere, and Veeva Vault Safety. It can also be the safety database for the full ICSR and the E2B(R3) file. A reviewer accepts or overrides the draft.

How does PV case intake work?

Open the workspace, paste a narrative or choose a PDF, Word, text, email, or image file. Parsing happens in your browser. You review the draft field by field. The intake form is the case screen, not a separate patient portal.

Does it handle AE, SAE, and SUSAR cases?

You can process those narratives. The draft flags seriousness and expectedness, which a qualified person uses when deciding whether a case is an SAE or a SUSAR. The software does not make that regulatory call.

Can I use it for PQC reporting?

If a product quality complaint includes an adverse event, you can paste that narrative into the same intake. AE Connect is not a complaint-handling system or a QMS.

Does AE Connect replace Oracle Argus, ArisGlobal, or Veeva Vault Safety?

It can feed those safety databases, or it can be the safety database for the full ICSR and the E2B(R3) file. See Argus, LifeSphere, and Vault Safety.

Does it maintain the company core data sheet or write aggregate reports?

No. Expectedness in the draft is a suggestion to check against the current company core data sheet or Investigator's Brochure. Aggregate reports, including the IND annual report and DSUR, stay with your safety process.

From the notebook

Case intake, Day 0, and reporting lag Why many reactions never become a report E2B(R3) ICSR submission: what IND sponsors need E2B(R3) readiness checklist Argus, Safety One, and Veeva for early-phase teams AE intake versus full pharmacovigilance The first IND PV plan, the CCDS, and aggregate reports The drug safety inbox at a small biotech The missing layer in adverse event intake PV case intake forms Adverse event reporting: AE and SAE SUSAR reporting Product quality complaint reporting E2B(R3) ICSR submissions AI pharmacovigilance case processing PSUR, PBRER, and DSUR How AE Connect works with Oracle Argus How AE Connect works with ArisGlobal LifeSphere How AE Connect works with Veeva Vault Safety Feature notes