Processes

What will AGI do for Capture and report adverse events?

A patient, healthcare provider, or clinical site reports a negative side effect or health issue associated with a specific product.

Trigger
A patient, healthcare provider, or clinical site reports a negative side effect or health issue associated with a specific product.
Outcome
The adverse event is medically evaluated, codified, and submitted to the relevant regulatory authorities within mandated legal timeframes.

The work itself

Grounded Work Profile

Measured by

  • On-Time Regulatory Submission RateprocessProfile
  • Case Processing Cycle TimeprocessProfile
  • First-Pass Coding AccuracyprocessProfile
  • Follow-Up Completion RateprocessProfile

Key steps

  • Receive and log the initial adverse event reportprocessProfile
  • Triage the event to determine severity and reporting timelinesprocessProfile
  • Enter case data and apply standard medical codingprocessProfile
  • Request follow-up information to complete the clinical pictureprocessProfile
  • Perform medical review and causality assessmentprocessProfile
  • Submit the safety report to regulatory health authoritiesprocessProfile
  • Archive the case and update aggregate safety databasesprocessProfile

How AGI delivers it

Four ways AGI delivers for Capture and report adverse events

  • Autonomous Agents as digital employees

    Hire a digital employee that does the job under earned, supervised autonomy.

    Agents.do
  • Business-as-Code

    Encode how your work runs, once, as software that executes itself.

    Platform.do
  • Services-as-Software

    Get the professional outcome delivered as software, priced on results, not headcount.

    Services.do