Safety

SURAI provides a connected workspace for organizing incoming safety information, case-related work, qualified review activities, reporting coordination, responsibilities, and ongoing safety follow-up.

• Organize incoming safety information

  Capture and structure incoming information, establish the relevant case context, and make missing information or required follow-up visible.

• Support qualified case assessment

  Coordinate review activities, supporting information, responsibilities, and documented outcomes while keeping medical and safety judgments with qualified reviewers.

• Coordinate reporting work and timelines

  Track reporting requirements, due dates, package preparation, status, and supporting documentation without implying automated regulatory submission.

• Maintain visibility into ongoing safety review

  Organize aggregate review and signal-management records, priorities, decisions, assigned actions, and follow-up without claiming automated signal detection.

• Use AI with human oversight

  Ask SURAI to find and summarize available information, identify missing context, and highlight work requiring attention. Qualified reviewers remain responsible for assessments, reportability decisions, and safety actions.

• Keep supporting work connected

  Link role-based access, document versions, tasks, notifications, and audit history to the safety records and activities they support.

Together, these capabilities help safety teams coordinate operational work with greater visibility and traceability while preserving qualified human review and decision-making.