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.
Drug safety · electronic intake
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.
Name, a company email, and a company name request a 14-day sandbox with unlimited cases. We set up the account. The company name becomes the Organization. How intake works.
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.
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.
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.
01
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.
02
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.
03
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.
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.
Sandbox
14 daysName, a company email, and a company name request a 14-day sandbox. We set up the account. The company name becomes the Organization. Unlimited cases. Electronic intake, customization, AI triage, and E2B(R3) export.
Annual
From $36,000Starter, Growth, and Scale. Customized intake, and a path that feeds your safety database or uses AE Connect for the ICSR. See pricing.
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.
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.
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.
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.
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.
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.
Name, a company email, and a company name request a 14-day sandbox trial with unlimited cases. We set up the account. The company name becomes the Organization. The sandbox covers electronic intake, form customization, AI triage, and E2B(R3) export. Annual subscriptions are Starter at $36,000, Growth at $72,000, and Scale at $120,000 per year.