What "automated" means in Edriza
Pharmacovigilance has always depended on careful people reading carefully. Much of that reading, however, is routine: screening articles that turn out not to be cases, copying patient and product details into the safety database, checking that a date in the narrative matches the date in the form. Edriza automates that routine work end to end, from the source to the E2B(R3) submission. What it does not do is take the decisions that your SOP reserves for qualified people. The result is a fully automated workflow with human oversight: automated end to end, your experts stay in control.
What the AI does
- Reading. Articles, mails, partner reports and uploaded documents are read in full, not only their abstracts or subject lines.
- Data entry. Patient, reporter, product, reaction and history data are extracted and entered into the case, with MedDRA coding.
- Assessment. Product check, validity, seriousness, expectedness and causality are assessed and the reasons are written down.
- Output. Narratives, E2B(R3) XML, line listings for aggregate reports and signal candidates are prepared from the case data.
- Monitoring. RA Monitoring watches regulatory authority websites for safety communications and changes in requirements that concern your products.
How control is kept
Every case is handled by two independent AI agents. Their results are compared, and a third, quality-control agent checks the case against the source. Agreement on a clear case lets the work move on. Disagreement, missing information or a rule in your SOP sends the case to an expert, with the evidence and the open question laid out. Your SOP decides which steps need a person and who may sign them off.
Every action, by an agent or by a person, is written to the audit trail with who or what acted, when, and why. That record is what you show an auditor or an inspector: not a promise that the AI is right, but the evidence of what was checked and by whom.
Standards it works to
Case handling follows ICH E2A (definitions and seriousness), ICH E2D (post-approval safety data management), ICH E2B(R3) (the electronic ICSR format) and GVP Module VI (collection, management and submission of reports of suspected adverse reactions). Coding uses MedDRA with your licensed version. Aggregate reports and signal management follow the corresponding ICH and GVP guidance, described on the aggregate reports and signal management pages.
One platform, no hand-offs
In many PV departments each activity has its own tool: one for literature, one for the safety database, one for E2B, another for aggregate reports and signals. Every hand-off between them is a copy of the data and a chance for error. Edriza runs these activities in one platform, with one sign-in, one audit trail and one data set, and no additional subscriptions are needed for them.
What stays with your team
- Medical judgement where your SOP asks for it, for example causality or the seriousness of a borderline event.
- Sign-off of aggregate reports and decisions on signals.
- The SOP itself: what is checked, the thresholds, and who approves.
- Oversight of the system through the audit trail and the quality figures.
Getting started
Most companies start with one source, often literature monitoring or the safety mailbox, run it beside their current process, compare the results, and then move more sources across. Contact us to plan it for your products and markets.