Every marketing authorization holder shares an obligation that never pauses: the scientific and medical literature has to be watched, continuously, for anything that could signal a new or changing risk to a patient. It is one of the oldest disciplines in drug safety and, paradoxically, one of the least modernized. Teams still spend the bulk of their week reading abstracts to find the small fraction that actually matter.
Cloudbyz Evidence IQ is built to change that equation. It is an AI-powered literature surveillance agent that finds the safety-relevant science, ranks what matters, and turns it into a review-ready case — so your team spends its time on decisions, not searching.
Under EU Good Pharmacovigilance Practices (GVP Module VI) and equivalent expectations from the FDA and other regulators, sponsors and MAHs must systematically screen published literature for suspected adverse reactions and other safety-relevant information about their products. For substances covered by the EMA's Medical Literature Monitoring service, screening cadence is effectively weekly; for everything else, companies run and document their own searches on a comparable rhythm.
The obligation is precise and unforgiving. A single valid individual case safety report (ICSR) buried in a case series can start a 15-day reporting clock. Search strategies must be documented and reproducible. Every screening decision — accept, reject, or flag — has to be defensible years later in an inspection. And the volume only grows: new indications, new geographies, biosimilars, combination products, and an ever-expanding body of published science all widen the surface area a safety team is accountable for.
The difficulty is not that the science is hard to find. It is that finding it is only the first of many manual, repetitive steps.
A typical workflow means running structured queries across multiple databases, exporting results, de-duplicating overlapping hits, reading through hundreds of abstracts to separate genuine safety signals from noise, retrieving full text for the borderline cases, extracting the patient, product, and event details by hand, coding them, and then re-keying all of it into a safety database. Each handoff is a place where time is lost and where a tired reviewer at the end of a long queue can miss the one abstract that mattered.
The cost is threefold. It is operational — skilled scientists spend hours on screening that could be spent on assessment. It is temporal — days can pass between publication and a drafted case, compressing the window to meet reporting timelines. And it is compliance-related — inconsistent screening rationale and thin audit trails are exactly what inspectors probe.
Evidence IQ collapses that fragmented chain into a single, guided flow. Instead of a person orchestrating five tools, the agent does the mechanical work and hands the team a prioritized, explained, and pre-drafted output to review. Five capabilities anchor the experience.
Ask in plain language. You describe what you are watching for — a product, an active substance, a safety topic of interest — in ordinary words, and the agent searches every connected source at once. There is no need to hand-craft database-specific syntax for each system.
See why it matters. Every result comes back with a clear relevance score and a short, human-readable reason it was flagged. Reviewers are not staring at a raw list of titles; they are looking at a ranked queue that already explains its own reasoning, so the highest-value items rise to the top.
Review in one place. Accept, reject, or flag each finding from a single queue that learns as you go. The screening decisions your team makes feed back into how the agent prioritizes, so the queue gets sharper over time rather than resetting every week.
Case ready in clicks. Selected articles become a drafted safety case with the relevant fields already populated — patient, product, event, and source details extracted from the source and carried forward, eliminating the re-keying that consumes so much of the traditional process.
Works with your systems. Finished cases push straight into your safety platform with no re-typing. Whether your ICSR intake lives in Cloudbyz Safety or an existing pharmacovigilance database, the drafted case flows to where your process already runs.
For the people accountable for the function, the payoff shows up in four places.
That last point deserves emphasis. Audit readiness in Evidence IQ is not a report you generate later — it is a property of how the agent works. Because the search strategy, the relevance rationale, and every accept/reject action are captured as the work happens, the documentation an inspector expects is a byproduct of the process rather than a separate project.
Automation in a regulated safety function only earns trust if the human remains the decision-maker. Evidence IQ is deliberately designed as a human-in-the-loop system. The agent searches, ranks, and drafts — but your team confirms every finding and approves every case before a single click pushes it to your PV system. Nothing reaches your safety database without a qualified reviewer signing off.
This is the right posture for pharmacovigilance. It removes the drudgery that causes fatigue and error while preserving the professional judgment that regulators, and patients, depend on. The scientist's expertise is spent where it is most valuable — on assessment and causality — instead of on copy-paste.
Evidence IQ is built for the roles closest to product safety. Pharmacovigilance teams get a faster, more defensible path from publication to ICSR. Medical affairs stays ahead of the emerging evidence around their products without living inside a dozen databases. And safety officers gain a consistent, traceable screening process they can confidently put in front of an auditor.
Evidence IQ is one of Cloudbyz's stand-alone eClinical AI agents — purpose-built assistants that target a specific, high-effort task in the clinical and safety lifecycle. As a Salesforce partner solution, it fits naturally alongside the broader Cloudbyz unified platform spanning CTMS, eTMF, EDC, CTFM, and Safety/PV, while remaining flexible enough to feed whatever safety system a customer already runs. The agent does one thing exceptionally well and connects cleanly to the systems around it, so adopting it does not require ripping out an existing pharmacovigilance stack.
Literature surveillance will always be a regulatory necessity. It does not have to remain a manual bottleneck. By turning an afternoon of screening into a ranked, explained, and pre-drafted queue — with the human firmly in control and the audit trail built in — Evidence IQ lets safety teams spend their expertise where it belongs: on protecting patients.
If your team is still juggling databases and re-keying cases, it may be time to see what one search, and one click to your PV system, can do.
Interested in a walkthrough of Evidence IQ for your pharmacovigilance workflow? Reach out to the Cloudbyz team for a demo.