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What is Pharmacovigilance software for clinical trials?

Pharmacovigilance software for clinical trials is used to track and manage safety data related to investigational drugs. It helps research teams collect, review, and report adverse events that occur during a study. The software ensures that safety information is captured accurately and sent to regulators within required timelines.

The system supports case intake, data entry, signal detection, and regulatory reporting. It also includes tools to manage follow-ups, generate narratives, and maintain a clear audit trail. Pharmacovigilance software helps trial sponsors meet safety standards while reducing the risk of delayed reporting or missed events.

 

All Pharmacovigilance Software

Top benefits of pharmacovigilance software for clinical trials:

  • Faster adverse event reporting: Teams can log and submit safety cases quickly.
  • Improved data accuracy: The software checks for missing or incorrect safety details.
  • Regulatory compliance: Built-in rules ensure reports meet global safety standards.
  • Real-time monitoring: Safety teams can track new events as they are entered.
  • Audit-ready records: Every change is logged and stored securely.
  • Signal detection tools: The software helps identify patterns in safety data.
  • Centralized case management: All safety reports are stored in one system.
  • Workflow automation: Follow-ups and tasks are assigned automatically to reduce delays.

 

betterclinical showcases over 400 clinical trial software

For an infographic representation of all these software solutions, have a look at the Clinical Trial Software Landscape.

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