DSUR & PBRER Automation

Periodic safety reporting—Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)—demands comprehensive aggregation of clinical safety data, literature reviews, and integrated benefit-risk analysis, all formatted to exacting ICH E2F and E2C(R2) standards. Pharmacovigilance teams spend 4-6 weeks per report on manual data extraction, signal detection, and narrative synthesis, creating capacity bottlenecks and delaying submissions.

Workflow goal

Automate safety data aggregation, signal detection, and ICH-compliant report generation to reduce preparation time to 3-7 days while enhancing signal identification quality.

Stakeholders

  • Head of Pharmacovigilance

  • Drug Safety Physicians

  • Safety Scientists

  • Regulatory Affairs

End-to-End Agentic Flow
1

Data Aggregation

  • Extract adverse event cases from safety databases

  • Retrieve clinical trial exposure and efficacy data

  • Pull relevant laboratory and vital sign data

2

Signal Detection & Analysis

  • Perform disproportionality analyses (PRR, ROR, EBGM)

  • Identify emerging safety patterns and event clusters

  • Conduct temporal trend analysis

  • Compare against therapeutic class benchmarks

3

Literature Surveillance

  • Search medical literature databases (PubMed, EMBASE)

  • Filter for safety-relevant publications

  • Extract key findings and case reports

4

Report Generation

  • Generate all required ICH tables and line listings

  • Synthesize safety narratives with signal assessments

  • Integrate benefit-risk analysis sections

  • Ensure cross-referencing and data consistency

5

Medical Review

  • Route draft to pharmacovigilance physicians

  • Incorporate clinical interpretation and feedback

  • Validate data accuracy and completeness

6

Quality Assurance & Approval

  • Automated validation checks

  • Electronic signature workflow

  • Generate submission-ready PDF

Platform features highlighted

  • Multi-database integration and reconciliation

  • Advanced statistical signal detection

  • Automated literature monitoring

  • ICH-compliant formatting and validation

  • Medical officer review of AI-generated narratives

  • Safety scientist validation of signal assessments

  • Quality assurance review before submission

  • Read-only access to safety databases

  • Report preparation time (weeks → days)

  • Signal detection sensitivity

  • Data consistency error rate

  • ICH format compliance

  • Submission timeline adherence