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Safety

AE / SAE Reporting

Capture adverse and serious adverse events the moment they happen. Structured forms guide severity and causality capture, while automated escalation alerts notify the right people without delay.
Built forSubjectInvestigatorCRC
Safety
  • Capabilities

What you get

  • 01
  • Real-time subject reporting
  • 02
  • Severity & causality capture
  • 03
  • Automated escalation alerts
  • 04
  • SAE workflow & follow-up tracking
  • 05
  • Exportable safety reports

See AE / SAE Reporting live

Book a tailored walkthrough and we'll show ae / sae reporting configured around your protocol.

  • Built for
SubjectInvestigatorCRC
Request a demo
  • How it helps
AE/SAE Reporting shortens the gap between an event occurring and the right people knowing about it. A subject can flag a symptom from the mobile app the moment it happens; the site receives it instantly and the CRC/PI complete structured severity and causality assessments on desktop. Serious events trigger automated escalation to the PI and safety team, and every report is tracked through follow-up to resolution with an exportable safety record.

Safety

AE / SAE Reporting

Purpose-built for hybrid & decentralized trials: one workflow across desktop and mobile.

  • One hybrid platform

Desktop for study teams, mobile for subjects

AE / SAE Reporting works across the ProCTTH hybrid platform. Site staff (CRC, PI, CRA) work on the desktop web console, while subjects access the study from the mobile app.

Desktop console

CRC · PI · CRA

CRC and PI review incoming events, complete severity and causality assessments, manage the SAE workflow and follow-up, and export safety reports for the sponsor.

Mobile app

Subject

Subjects report symptoms and adverse events in real time from the mobile app, attach photos or notes, and respond to follow-up questions.
  • How it works

From setup to outcome

  • 01

Report the event

Subjects flag symptoms from the app, or site staff log events directly, in real time.

  • 02

Assess structurally

CRC/PI complete guided severity and causality assessments on the console.

  • 03

Track to resolution

Each event is followed up and tracked to closure, with exportable safety reports.

  • FAQ

Common questions.

Can subjects report events themselves?
Yes. Subjects can report symptoms and adverse events in real time from the mobile app, with photos and notes.
How are serious events escalated?
SAEs trigger automated escalation alerts to the PI and safety team so nothing waits on manual hand-off.