Monitor ADR submissions from web forms and email, extract MedDRA terms with Claude AI, enrich with historical signals, persist to a PV Google Sheets database, and notify the PV team for expedited regulatory reporting.
This AI agent ingests ADR reports from web forms or email. It codes events with Claude AI against MedDRA, enriches data with historical signal information, and stores the case in a PV database. It triggers expedited regulatory alerts for serious/unexpected events and maintains an auditable, inspection-ready trail.
Automates key PV intake and processing tasks end-to-end.
Ingest ADR reports from web forms or email
Validate required fields, assign a unique case ID, and standardize reporter data
Deduplicate submissions within a 10-minute window to avoid duplicates
Code MedDRA terms and assess seriousness, causality, and expectedness using Claude AI
Enrich records with historical signal data and PV context
Persist a structured PV case to Google Sheets and trigger expedited regulatory alerts for serious/unexpected events
This AI agent addresses common bottlenecks in PV case handling. It delivers concrete before/after outcomes.
A simple 3-step flow anyone can follow.
Receive ADR reports via webhook or email, validate required fields per ICH E2B(R3), assign a case ID, and apply a temporary deduplication window.
Claude AI extracts MedDRA PTs, determines seriousness, causality, and expectedness, and enriches with historical signals.
Write the PV case to Google Sheets in an E2B-compliant format, check the regulatory clock, and notify the PV team for expedited reporting if needed.
One realistic scenario.
Scenario: A physician submits an ADR report via the patient portal at 2026-04-28 09:15 UTC. The AI agent ingests the form, validates required fields, assigns Case ID PV-20260428-001, and holds briefly for deduplication. Claude AI codes the event to MedDRA PT, assesses seriousness as Serious, and checks causality. It enriches with historical PV signals, persists the record to Google Sheets, and notifies the PV team for an expedited regulatory submission if indicated, creating an auditable trail.
Affects roles across PV, regulatory affairs, and IT.
Gains standardized MedDRA coding and faster case triage.
Ensures on-time regulatory reporting with clock checks and clear deadlines.
Centralizes ADRs for safety reviews and faster decision-making.
Provides auditable lifecycle data and performance metrics.
Simplifies integration with Claude AI and Google Sheets; reusable components.
Ensures privacy, data governance, and inspection-ready records.
Connects Claude AI, Google Sheets, and email/alerts.
Performs medical coding (MedDRA PT extraction), seriousness, causality, and expectedness assessments within the AI agent workflow.
Stores structured PV case records and audit logs; serves as the master safety record.
Delivers alerts to the PV team and regulatory affairs; surfaces deadlines for expedited reporting.
Practical scenarios for reliable ADR intake and PV processing.
Practical questions about how the AI agent handles ADR intake and PV processing.
The AI agent ingests ADR reports from web forms and emails automatically. It parses the content to extract required fields and standardize reporter data. It handles multiple languages where supported, and maps data to a consistent internal schema. If the submission misses non-critical fields, it flags the case for human review while preserving a complete audit trail.
All ADR data is processed with access controls and audit logs. PII is minimized and stored only where required for safety reporting. Data in Google Sheets is accessible only to authorized roles, and transfers use secure channels. The design supports regulatory compliance and allows for data retention policies to be enforced.
Claude AI analyzes the narrative and attachments to extract MedDRA PTs, then assesses seriousness, causality, and expectedness based on defined criteria. It continuously refines mappings against historical data and PV context. The output is mapped to a structured E2B-compliant record for storage. Reviewers can override or annotate codes when necessary.
Submissions are checked against reporter identity, timestamp, and case identifiers within a 10-minute window. If a match is found, the system flags the submission as a potential duplicate and prevents multiple PV records from being created. A log entry preserves the deduplication decision for audit purposes.
The agent tracks ICH E2A timelines and the regulatory clock for serious/unexpected events. It holds submissions within the allowed windows, and notifies the PV team when a report is due. If criteria are met, it triggers the regulatory submission workflow to ensure timely reporting.
Yes. Thresholds for PRR and ROR can be configured within the enrichment node. This allows tailoring sensitivity to your therapeutic area and data volume, while still maintaining an auditable record of decisions.
The audit log captures every action from ingestion to submission, including data changes, coder decisions, deduplication outcomes, and alerts sent. It supports EMA/FDA inspection readiness by providing a complete chain of custody and traceability.
Monitor ADR submissions from web forms and email, extract MedDRA terms with Claude AI, enrich with historical signals, persist to a PV Google Sheets database, and notify the PV team for expedited regulatory reporting.
