Preparing your experience...
Preparing your experience...
Generate professional pharmacovigilance documents powered by AI agents. Each report pulls live data from FDA FAERS, DailyMed, PubMed, and other regulatory sources.
Signal Evaluation Report
ICH E2E
Detect and evaluate potential safety signals using FDA adverse event data, disproportionality analysis, and literature review.
Produces:
PDF report with signal scores, label cross-reference, and recommended actions
~30 seconds
Causality Assessment Report
WHO-UMC / Naranjo
Assess whether a drug caused an adverse event using the Naranjo algorithm and WHO-UMC criteria.
Produces:
PDF report with causality scores, question-by-question analysis, and overall verdict
~20 seconds
Benefit-Risk Assessment Report
ICH E2C(R2)
Evaluate whether a drug's therapeutic benefits outweigh its safety risks using quantitative analysis.
Produces:
PDF report with benefit-risk ratio, risk ranking, and management recommendations
~45 seconds
ICSR / CIOMS I Form
ICH E2B(R3)
Generate an Individual Case Safety Report in CIOMS I format from structured case data.
Produces:
PDF CIOMS I form + E2B(R3) XML
~5 minutes
Periodic Safety Update Report
ICH E2C(R2)
Generate PSUR/PBRER sections from aggregated safety data across reporting periods.
Produces:
PDF periodic report with signal summary and benefit-risk re-evaluation
Risk Management Plan
ICH E2E / FDA REMS
Generate risk management plan elements including safety specifications and risk minimization measures.
Produces:
PDF RMP summary with risk characterization and mitigation strategies
Data sources: All reports are generated using live data from FDA FAERS, DailyMed, PubMed, ClinicalTrials.gov, and other regulatory databases. Reports are for informational purposes and do not constitute regulatory submissions.