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Multiple patients found in this document
This source describes more than one patient case. Select which one to build the case for.
New Case — Extract from Source Document
Where the event occurred. A product counts as yours only if its MAH permissions in the company product list cover this country.
Results will appear here.
▸ Paste extraction JSON manually instead
Import Case
Bulk import (e.g. E2B(R3) XML, CSV batch) is not built yet — this is a placeholder for that workflow. For now, use New Case to create cases one at a time from extraction output.
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Case
General
Patient
Product
Event
Analysis
Activities
Attachments
Regulatory Reports
Case Identification
Not a distinct E2B code. Saving fills this into any event below with no country set yet — it won't overwrite an event that already has a different one.
Literature Reference (C.4)
Study Identification (C.5)
Reporters (Primary Source — C.2)
Sender / Receiver (C.3)
Other Case Identifiers (C.1.9/C.1.10)
Patient Demographics
FDA Extended Patient Info (full identity, for direct consumer reports)
Medical History & Current Conditions (D.7)
Death Information (D.9)
Past Drug Therapy (D.8)
Drugs taken before this case's onset — distinct from Product tab drugs, which cover drugs taken during the case.
Parent Information (fetus/breastfeeding cases)
Parent Medical History (D.10.7)
Parent Past Drug Therapy (D.10.8)
Lab Data (F.r)
Drugs
Vaccines (G2.k)
Adverse Events
Click "Coding, Labelling & Causality" on an event to open its own dedicated view.
Narrative
Company Comment
Reporter's Comment
Abbreviated Narrative (PSUR Comment)
Overall Case Assessment
Routing / Workflow History
Action Items
Contact Log
Source Documents / References
File storage isn't wired in yet — this tracks references (filename + classification) only.
Regulatory Reports
Covers the core sections (identification, reporter, sender/receiver, patient, drugs, reactions, causality, narrative) — not yet every field in the schema. The CIOMS form is structurally faithful (box numbers, labels, section order) but not a pixel-exact copy of the printed template. Validate against the official ICH specs/CIOMS template before a real regulatory submission.
Proposed Change(s)
Review each proposal below. Nothing is saved until you click Apply on that item.
Revisions
One entry per explicit save. Click a revision to open a read-only view of the case as it was at that point.
Unsaved Changes Found
This is a local recovery copy from this browser only — it was never sent to the server. Restoring it will NOT save it either; you'll still need to click Save afterward.
Unsaved Changes
This case has changes that haven't been saved yet. What would you like to do?
Case Created
Click the case number to open it now, or close this to start a new intake.
No company product in this document
Learned conventions
What this company's users have taught the assistant from their chats. They apply to this company only and are added to the shared skills when a prompt is built. A new rule needs one user; when users disagree, the answer with more distinct users wins (a tie keeps the current one); changing a rule in the base skills needs more than one user.
Conventions
Change log
Possible Similar Cases Found
Comparing product, event, patient details, and narrative against existing cases in your company. Use "Show Differences" on a match to see exactly what's new before deciding.
Pending Follow-up Information
New intake information was queued against this case. Review the differences below, then accept to apply them or dismiss to discard the proposal (the case itself is untouched either way until you choose).
Add Event
Enter the event term as reported (E.i.1.1a). It is coded to MedDRA automatically using AI-suggested search terms and the MedDRA dictionary.
Add Product
No exact MedDRA match — pick one
The dictionary search didn't find an exact match for this term. Choose the closest candidate below, or leave the event's existing coding as-is.