AI‑Native Pharmacovigilance
Vigintake reads source documents, emails and scientific literature, extracts and codes the case, drafts the narrative in your template and produces an E2B(R3) file for your safety database.
Book a Demo ↗
Safety CaseIllustrative example“The patient reported persistent nausea following the initiation of treatment. The event was reported by a healthcare professional.”
A healthcare professional reported persistent nausea in a patient following initiation of treatment.
Ready for clinical reviewEvidence and source available
01 · Intake
Upload source documents, safety mailbox emails or E2B(R3) files from partners, in any of 100+ languages. A follow-up is attached to its case and its changes are shown before they are applied.
Case Processing ↗02 · Extraction
Patient, product, reaction and reporter data go into the E2B(R3) structure, each value linked to where it appears in the source. A MedDRA term is proposed for every verbatim and confirmed by the reviewer.
How a Case Is Processed ↗03 · Review
The narrative is drafted in your organisation's template. A safety scientist checks the case against the source, corrects it and exports the E2B(R3) file.
Output to Your Safety Database ↗100+
Source languages
Source documents in over 100 languages.80%
Less time drafting narratives
From source document to a narrative ready for review.4
Product domains in literature
Human, veterinary, medical device and cosmetic products.Vigintake sits between your incoming reports and your safety database. Reviewed cases leave as E2B(R3) files for Argus, ARISg, Veeva Vault Safety, VigiFlow or any system that imports E2B(R3). No migration.
Your safety database stays the system of record. Vigintake hands it a standard E2B(R3) file.
The reviewer sees the source document next to each extracted field and can check it in one click.
Every field is shown for review and correction before the case is finalised, and each correction is recorded.
URS, functional specification, risk analysis, IQ, OQ and traceability matrix, ready for your PQ.
Every edit, status change, coding decision and export is recorded with user, time, previous value and new value, in line with Annex 11 and 21 CFR Part 11.
Each organisation is isolated at the database layer. Sign-in is through Microsoft or Google single sign-on.
The model behind each extraction is stored with the case and included in its structured export.
Service providers, CROs and marketing authorisation holders use the same system with different set-ups.
PV Service ProvidersHow They Use ItProcess cases for several clients in one place. Each client has its own organisation, narrative template and audit trail, and no client can see another client’s data.
CROsHow They Use ItRun case intake and literature screening for each sponsor’s products, with the source of every value kept next to the case.
Marketing Authorisation HoldersHow They Use ItKeep case processing and literature screening in-house, or check the work of your PV vendor, with the full record of every case available to the QPPV.
Book a Demo
Send us two or three anonymised source documents. We will show you the extracted case, the MedDRA coding, the narrative and the E2B(R3) file.
