Pharma Intelligence OS
Explore a dedicated workspace for pharmacovigilance and regulatory intelligence workflows.
Where judgement
stays human.
Software can organise evidence, structure a case and flag a signal. It cannot decide that a case is medically valid. That line is explicit throughout the system.
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Ingest
Cases arrive from multiple sources and are normalised into a single structured record. Sources are preserved alongside the normalised form so a reviewer can always check the original.
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Structure
Case data is organised against the ICH E2B(R3) structure, with the elements a submission requires separated from the elements a reviewer needs to see first.
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Signal detection
PRR and ROR calculations surface disproportionate reporting so a reviewer can prioritise. A statistical flag is a prompt to look, not a finding.
Flag ≠ conclusion -
Qualified human verification
A qualified reviewer validates every consequential output: causality assessment, expectedness, seriousness and the narrative. The system records who decided and why.
Qualified reviewer -
Package
Verified cases are assembled into ICSR packages and periodic report drafts (PSUR, PBRER) with the review trail attached.
What is built
so far.
An honest table of what exists in the development branch and what is not validated. Software demonstration only.
| Area | Status |
|---|---|
| Data ingestion | Development; not validated here |
| Normalization | Development; not validated here |
| Intelligence layer | Development; qualified review required |
| Frontend | Published application interface; backend and end-to-end workflows not certified |
Do not enter patient information or confidential case data into a public demonstration.
Not a regulatory
submission service.
Three limits that matter more than any feature in this system.
Not medical advice
Software demonstration only. Not medical advice, a validated regulatory submission system or an autonomous clinical decision tool. Human verification is required.
Source and publication
Source availability and publication records do not certify the current Next revision. Review release notes, tests and deployment assumptions for your environment.
Where to go
next.
The current development branch, the published application preview, the published original and its permanent record.
The DOI identifies a published record. Consult that record for its exact version and files; it does not automatically identify the latest Next commit.
Start with your
review process.
Who reviews, what they need to see, and where the evidence has to come from. That is the integration conversation.