Keizer Case AI is the enterprise pharmacovigilance case software built to turn complex safety cases into structured, review-ready intelligence. By fusing LLM-assisted workflows with deterministic compliance controls, Keizer Case accelerates medical review without ever surrendering human authority or auditability.
Keizer Case AI combines intelligent automation with strict, deterministic guardrails to deliver end-to-end case safety processing.
Ingest incoming individual case safety reports (ICSRs), parse case signals, and dynamically prioritize critical risk items for immediate, actionable, high-priority human evaluation.
Navigate the MedDRA hierarchy with precision using AI coding suggestions tailored to full clinical context, reducing manual term searches while ensuring audit-ready medical reviews.
Automatically grade every case against an objective 0–100 quality benchmark to spot data gaps and eliminate costly, avoidable reviewer inconsistencies before sign-off.
Seamlessly synthesize patient data, complex lab results, and longitudinal event timelines into structured, compliant safety narratives and ready for regulatory submission.
Safety decisions require complete accountability. Keizer Case AI wraps powerful AI models inside controlled, validated operational environments.
Mandate independent medical assessments with controlled, dual-signature sign-offs at critical regulatory trial milestones.
Log every platform event, case revision, modification, and data change into an immutable, persistent chronological history.
Record precise timestamps alongside verified reviewer identities for every clinical decision, recommendation, and approval.
Ensure clinical command remains supreme—AI assists and scores, while certified reviewers validate, approve, and sign.
Streamline adverse event management with an auditable eight-stage workflow that combines AI-assisted processing with strict, human-approved regulatory sign-offs.
Import unstructured safety data into a centralized, organized workflow.
Automatically identify high-risk cases and route them by urgency.
Select and assign verified MedDRA hierarchy terms using contextual AI recommendations.
Evaluate data completeness and quality against a standardized 0–100 rating scale.
Automatically compile accurate, structured regulatory safety narratives.
Qualified medical reviewers inspect, challenge, and refine case information.
Execute controlled dual electronic signatures to certify approval.
Archive the full lifecycle in a compliant, append-only historical log.
Standardize multi-product safety evaluations and maintain uniform narrative quality across vast global therapeutic portfolios.
Accelerate aggregate case intake throughput and hit aggressive client delivery deadlines without ballooning operational headcounts.
Eliminate redundant clerical overhead and drastically minimize repetitive manual errors across massive incoming event backlogs.
Cut out distracting navigation burdens and channel specialized clinical acumen directly into decisive patient safety risk evaluations.
