End-to-end safety case management
Manage the whole Individual Case Safety Report lifecycle in one secure, traceable workflow: book-in, data entry, coding, causality, medical review, QA, submission and follow-up. AI helps at every step, and people make every decision.
Everything a case needs, in one workbench
Multi-channel intake
Email, call transcripts, chatbot, social media, literature, partner and distributor reports, and E2B R2/R3 XML import.
Reads any document
Audio transcription, OCR for scanned PDFs and images, and parsing of Word and CSV source documents.
AI field extraction
Reporter, patient, product, event and narrative pulled into structured case fields for you to confirm.
Triage & classification
Serious AE, AE or non-case, decided by an AI model with a machine-learning fallback.
Duplicate detection
Similar cases are flagged before data entry, using a configurable similarity threshold.
MedDRA & WHO-Drug coding
AI-suggested codes for events and medicines, which coders review and confirm.
Automated causality
Naranjo and WHO-UMC assessments, one or both, from Certain to Unassessable.
Narrative drafting
Case narratives generated from the structured data, ready for your medical writers to refine.
Medical review cockpit
Event-level seriousness, expectedness and reportability. Approve, request follow-up, escalate to signal or return.
AI review, side by side with the case
Narrative summaries, suggested labels and a causality hint sit next to the source, clearly marked as suggestions for your reviewers to confirm.
A guided path from Day 0 to submission
Each stage records who completed it and when. Moving a case back needs approval and a reason, and follow-up versions stay linked to the original case.
Walk through a caseTriage & book-in (Day 0)
Preprocessing, extraction, validity check, duplicate search and classification.
Data entry
Case forms, pre-filled by AI, completed and checked by the case processor.
Coding & causality
MedDRA and WHO-Drug coding, plus Naranjo or WHO-UMC assessment.
Medical review
A physician assesses each event and approves, requests follow-up or escalates to signal.
Quality review
QA approves with an e-signature, or raises a query back to medical review.
Lock & submit
Required-field check, E2B(R3), CIOMS I or MedWatch output, and a record of the submission and acknowledgement.
Follow-up & close
Follow-up versions reset the 15-day clock. Cases close, archive or are nullified with a reason.
Regulatory output and real-time oversight
E2B(R3) export
ICH E2B(R3) XML generated from the case, with a pre-submission check for required fields.
CIOMS I & MedWatch
Generate CIOMS I, FDA MedWatch and PDF case reports directly from the case record.
Regulatory clock
Automatic due dates for 15-day serious, 90-day non-serious and follow-up reports, with breach alerts.
Per-region deadlines
Timelines set for each authority (FDA and EMA), and configurable for your partners.
E2B import
Bring in E2B R2 and R3 files from partners and licensees, mapped straight into the case form.
Submission tracking
Submission date, receipt and acknowledgement number recorded on every report.
Intake operations
My ICSRs, drafts, returned cases, pending follow-ups, ready to submit and overdue, at a glance.
Safety command center
A PV lead view of high-risk cases, AI-detected serious cases and serious 15-day ICSRs.
Case aging
Open cases by age band (0–7, 8–15, 16–30 and 31+ days), so bottlenecks show up early.
Submission timelines
On-time and breached reports, split by 15-day and 90-day obligations.
QA metrics
Quality review queues, returned-by-QA rates and reviewer throughput.
My productivity
Personal workload and completion reports for every case processor.
Case processor
Book-in, data entry, coding and follow-ups.
Medical reviewer
Seriousness, expectedness, causality and sign-off.
QA reviewer
Quality checks, queries and e-signed approval.
PV lead
Command center, workload and compliance oversight.
Submission specialist
Regulatory output and acknowledgement tracking.
Signal specialist
Receives cases escalated to signal.
Compliance officer
Audit trail, GDPR and CAPA oversight.
Auditor
Read-only inspection mode across all records.
Designed for inspection day
Built around 21 CFR Part 11, ICH E2B(R3), EMA GVP and ALCOA+ principles.
Append-only audit trail
UTC timestamps, user, role, IP and browser for every create, update, approve and submit. Exports to CSV.
e-Signatures
Password plus reason for QA approval. The meaning, method (password or MFA) and time are all recorded.
ALCOA+ checks
Data-integrity checks run before an ICSR is created or updated.
AI decision log
Model, inputs, outputs, confidence and human overrides are kept for every AI suggestion.
AI assistance at every step of the case
From book-in to narrative, AI does the first pass and your processors, physicians and QA reviewers make the decisions.
Extraction & triage
Structured fields from any document, with serious, non-serious or non-case triage.
Coding suggestions
AI-suggested MedDRA and WHO-Drug codes for coders to confirm.
Narrative drafting
Case narratives drafted from the structured data, ready to refine.
AI decision log
Model, inputs, outputs, confidence and any human override are recorded.
Explore the connected suite
Process cases faster, without losing control
See book-in, coding, medical review and E2B(R3) output on your own sample cases.