MedDRA Coding
A proposed term for every verbatim, shown with its code and whether it came from an exact match or from the model. The reviewer confirms it, and the MedDRA version stays with the code.
Case Processing
AI Case Processing for ICSRs
Vigintake reads each incoming report, extracts the case into the E2B(R3) structure, proposes MedDRA codes and drafts the narrative. Your safety scientist reviews it against the source and exports a validated E2B(R3) file.
Safety CaseIllustrative exampleSource
Document
“The patient reported persistent nausea following the initiation of treatment. The event was reported by a healthcare professional.”
↳
Patient reportOriginal source preserved
Received for assessment
Extracted
Fields
- Adverse event
- Nausea
- Reporter
- Healthcare professional
- Source language
- English
- MedDRA PT
- Proposed for review
Linked to source evidence↗
Narrative
Draft
A healthcare professional reported persistent nausea in a patient following initiation of treatment.
✓
Ready for clinical reviewEvidence and source available
E2B(R3) after approval↗
The Challenge
Where Case Processing Time Goes
Most of a case processor’s day goes into copying data from source documents, coding it and writing the narrative, before any medical judgement is applied.
- 01
Manual Data Entry
Case processors read PDFs and emails and type the data into the safety database field by field, then check it again.
- 02
Rework After QC
MedDRA coding choices, missing fields and inconsistent narratives send cases back for another round before they can be submitted.
- 03
Reporting Deadlines
Case volumes change from week to week. The 15-day and 90-day reporting deadlines do not.
How It Works
How a Case Moves Through Vigintake
Four steps from the source document to an E2B(R3) file. The safety scientist reviews and corrects the case before it leaves.
- 01
Upload
Upload a PDF source document, a safety mailbox email or an E2B(R3) file. A follow-up is uploaded from inside its case, so it is always attached to the right record.
- 02
Extract and Code
The data is extracted into the E2B(R3) sections for case identification, primary source, patient, reaction, drug and narrative. A MedDRA term is proposed for each verbatim.
- 03
Draft the Narrative
The narrative is written in your organisation’s template, from the data in the case.
- 04
Review, Validate and Export
The reviewer checks every field against the source, confirms the coding and runs the E2B(R3) validation. The export is an E2B(R3) file for your safety database, with every step in the audit trail.
Capabilities
What Is in the Case Processing Module
All of it is covered by the GAMP 5 validation package: URS, functional specification, risk analysis, IQ, OQ and traceability matrix.
Narrative Drafting
Narratives written in the template your organisation already uses, so every case reads the same way regardless of who processed it.
Follow-Up Handling
Changes from a follow-up are listed against the current values. Nothing is applied until the reviewer confirms, and the previous value is kept in the audit trail.
E2B(R3) Validation
Six checks before export: data types, mandatory elements, a crosswalk between the file and the stored case, XPath conformance, the EMA business rules and the E2B(R3) schema.
Source Links
Extracted values link back to where they appear in the source document, and the original file stays with the case in its original format.
Audit Trail
Uploads, edits, coding decisions, status changes, validation runs and exports are recorded with user, time, previous value and new value.
Who It's for
Who Uses It
PV Service Providers and CROs
Process cases for several clients from one system. Each client is a separate organisation with its own narrative template, users and audit trail.
- A narrative template per client
- Client data separated at the database layer
- Audit trail per client for sponsor audits
- Single sign-on with Microsoft or Google
Pharma and Biotech Safety Teams
Keep case processing in-house, or check the cases your PV vendor sends you, with the source and the full history of every case in one place.
- Inspection-ready case records
- GAMP 5 validation package for your PQ
- Output to the safety database you already use
- No database migration
Integrations
Output to the Safety Database You Already Run
Reviewed cases leave Vigintake as E2B(R3) files, so any safety database that imports E2B(R3) can receive them. Your database stays the system of record and submission stays in your process.
In: PDFIn: Email (.eml)In and out: E2B(R3) XML
Get Started
Try It on Your Own Cases
Book a 30-Minute Call ↗Send us two or three anonymised source documents and we will process them in the call, from upload to E2B(R3).