Trialion — Intelligence in Every Phase
All modulesPart of the Trialion platform — one login, one audit trail
Report safetyComing

Safety

Adverse event capture, SAE workflows aligned to ICH E2A timelines, and a clean pharmacovigilance handoff with E2B(R3) support.

Join the waitlistSee how integrations cover this today
app.trialion.com
SAE workflow — initial report, 24h clock
Roadmap

Covered via integrations today.

Safety is on the Trialion unified-platform roadmap. Adverse and serious adverse events captured in the EDC reconcile and hand off cleanly to your safety database via ICH E2B(R3), with India PvPI reporting flows where applicable.

Supported Safety databases:Oracle ArgusArisGlobal LifeSphereIndia PvPI reporting
24h / 15-day
ICH E2A timelines tracked automatically
E2B(R3)
export to safety databases built in
1
reconciled safety dataset, no re-keying

What Safety does

Adverse event capture linked to the subject record
SAE workflow with 24-hour / 15-day timelines (ICH E2A)
Pharmacovigilance handoff and reconciliation
E2B(R3) export to safety databases
How it works

Safety in three steps

1

Capture

Adverse events are captured linked to the subject record — never in a disconnected system.

2

Workflow

SAE workflows track the 24-hour and 15-day clocks required by ICH E2A.

3

Hand off

Reconcile and export to your safety database cleanly via E2B(R3).

Frequently asked

Does this replace our PV database?+

It captures and reconciles AEs and SAEs and hands off cleanly via E2B(R3) to your safety database.

Are reporting timelines enforced?+

ICH E2A 24-hour and 15-day clocks are built into the SAE workflow with clear due dates.

Works hand in hand with

EDC & eCRF

Live

Design forms and capture clean data, fast.

Capture

eConsent

Roadmap

Informed consent that participants actually finish.

Capture

ePRO / eCOA

Roadmap

Patient-reported outcomes from any device.

Capture