Compliance clock
The 15-day and 90-day deadlines start when a case is received. Open cases sort into overdue, due soon and on track, and email alerts go out daily.
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IntelliBase tracks your 15- and 90-day clocks, drafts cases from source documents, and stops invalid E2B(R3) files before they leave your team.
Real IntelliBase screens on a demo workspace. Sample data.
Most teams still stitch case intake, deadlines and exports together by hand. That’s where days disappear.
Someone has to remember to check the tracker. Sooner or later, someone forgets.
Reporter emails and literature excerpts turn into hours of copy and paste.
An invalid E2B(R3) file shows up at the gateway, not at your desk.
One workflow replaces the inbox, the tracker and the export checklist.
Paste a reporter email or literature excerpt. IntelliBase drafts the case fields for you to review.
AI-assisted intakeYour team checks every suggestion in a guided editor, codes reactions from the MedDRA release your company has loaded and scores causality.
Reviewer QC stepValidate and download E2B(R3) XML, or a CIOMS I form. Invalid files are blocked.
Schema validatedWatch every clock, get alerts, and run signal analysis on your own case data.
Clock and signalsEach module does one job well and shares one case record.
The 15-day and 90-day deadlines start when a case is received. Open cases sort into overdue, due soon and on track, and email alerts go out daily.
Eight sections, MedDRA coding from your own licensed release and Naranjo causality scoring.
Every suggested field stays flagged until someone accepts it. Nothing is submitted automatically.
Run PRR, ROR and chi² on your own case data. Track each signal from first flag to closure.
Every change records who, what and when. Export the log as CSV for an inspection.
Keep each product’s ingredients, strengths and listed terms with their MedDRA codes in one place, with its RSI version and update date. Disable a product to free its plan slot.
Enters and edits cases, and prepares exports.
Returns a case with a note, or moves it forward.
Manages users, the plan and company settings.
Reads cases and the audit log. Can’t change anything.
Reviewer and auditor roles depend on your plan.
The system enforces these. Your team doesn’t have to remember them.
Every E2B(R3) file is validated against the ICH ICSR schema and business rules. If it fails, you see why and nothing is produced.
Row-level security is forced on every tenant table. Another company’s data stays out of reach, even if application code has a bug.
The database role can’t update or delete audit entries. Signal sign-offs also need the signer’s password.
Every plan includes the compliance clock, case editor and audit log. Ask us for pricing.
No. IntelliBase produces validated E2B(R3) files and CIOMS I forms. You submit them through your regulator’s gateway.
No. AI drafts fields from pasted text and suggests terms. A person reviews and accepts each suggestion, and nothing is submitted automatically.
Request access and tell us about your team. We set up your workspace and send your admin an invite.
Row-level security is forced on every tenant table in the database, and the app connects through a restricted database role.
Tell us about your team. We’ll set up your workspace and send your admin an invite.