Adverse Event Intake & Triage

Drug Safety ProcessX

Use automation to triage adverse event cases, whether they come from emails, phone calls, or the service desk.

There’s an increase in adverse event (AE) case volume due to new markets and products, evolving global regulations, multiple input channels, and outdated legacy systems. Truth be told, it’s unmanageable. The need for accurate and timely processing has never been more critical.

Automating individual case safety report (ICSR) processing is a good starting point for pharmacovigilance (PV) organizations. Reducing this manual effort of case intake, triage, data entry, and review leads to higher accuracy and lower costs.

Similarly, automation supports complaint handling and post-market surveillance (PMS) for medical device companies that struggle with the amount of incoming AE data and fragmented data sources.

Consolidate Adverse Events into a Single Source of Truth

ProcessX helps you apply innovative technology, optimize ICSR and PMS workflows, and use advanced analytics insights to cultivate higher-quality operations.

For example, in a safety intake scenario for PV and complaint handling, AI and machine learning are used to categorize and assess risk during AE intake and natural language processing (NLP) redacts personal information based on permissions. AEs are consolidated into a single platform (no need to retain emails), then generative AI analyzes large datasets and non-structured outputs and compiles reports.

See more scenarios—watch the on-demand webinar Integrated GxP Compliance.

Adverse Event Workflows

To help you prevail over the high volume of case intakes, the power of the ServiceNow platform enables workflows for AE intake and triage. ProcessX enables you to quickly triage cases whether they come from email, phone calls, the service desk or wherever.


ProcessX integrates with your existing quality system and includes early risk detection and an effective mitigation plan. It also helps your organization.

  • Eliminate rework, due to missing or inaccurate information
  • Enable more efficient intake and reporting
  • Provide real-time AE status and supporting information on individual and collective cases
  • Exchange safety information in a timely manner

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