Pharmacovigilance, engineered for the deadline.
IntelliBase is the multi-tenant ICSR safety platform that automates your compliance clock, drafts cases with AI, and keeps every submission audit-ready — built MENA-first, Arabic-fluent.
One platform, from intake to submission
Replace spreadsheets, email chains and generic case tools with a system built around the regulatory clock.
Automatic compliance clock
15-day expedited and 90-day periodic deadlines calculated the moment a case is received — with alerts before you're at risk.
AI-assisted case intake
Upload a reporter email or PDF and IntelliBase drafts a structured ICSR — MedDRA-coded, narrative included, human-in-the-loop always.
Guided ICSR editor
An 8-section wizard with live Naranjo causality scoring, completeness tracking and validation before every submission.
E2B(R3) export
Generate ICH-mapped E2B XML and CIOMS I forms in one click, with a clear disclaimer to validate before regulatory transmission.
21 CFR Part 11 audit trail
Immutable who / what / when on every change, plus electronic signatures for inspection-ready submissions.
Multi-tenant by design
Isolated workspaces per company, role-based access — Editor, Reviewer, Admin, Auditor — and seat-based plans that scale with you.
Designed around how safety teams actually work
Never miss a regulatory deadline again
Every case starts a clock the moment it's received. IntelliBase separates overdue, due-soon and on-track cases automatically, so nothing slips through email or spreadsheets.
- 15-day expedited and 90-day periodic rules, applied automatically
- Configurable alert thresholds with in-app and email notifications
- 97%+ on-time submission rate reported directly on your dashboard
Let AI draft the case. You stay in control.
Upload a reporter email, scanned PDF, or literature article. IntelliBase extracts patient, drug, reaction and seriousness data — every AI-suggested field is flagged until a human confirms it.
- Automatic MedDRA coding suggestions for reported terms
- AI-generated narrative drafts from structured case data
- Nothing submits without explicit human sign-off
A guided ICSR wizard, not a blank form
Eight structured sections — from reporter to causality — with live Naranjo scoring, a real-time completeness score, and validation that blocks incomplete submissions before they become a problem.
- Live Naranjo ADR probability scoring as you answer
- Duplicate detection and follow-up version chaining
- Part 11 electronic signature before every submission
Built for the region's regulators — in Arabic and English
Full right-to-left Arabic interface, local receiver profiles, and MENA data residency — not a bolt-on translation layer.
Packages that scale with your case volume
Every package includes the compliance clock, guided ICSR editor and audit trail. Upgrade for AI and enterprise controls. Contact us for pricing.
- Core ICSR editor & compliance clock
- Operational dashboard
- E2B(R3) export
- AI intake & MedDRA coding
- Everything in Growth
- AI-assisted case intake
- Reviewer / QC role
- Part 11 e-signatures
Ready to put your compliance clock on autopilot?
Start a 14-day trial — no credit card required. Your workspace is ready in minutes.