High-volume ICSR processing, priced per case not per seat
Many products across many markets produce a large obligation matrix and a case volume where cost per case decides the economics. PVgenix reduces the manual load with AI-assisted extraction and scoped straight-through processing, and resolves the product-by-market reporting matrix with a configurable rules engine instead of institutional memory.
Where volume breaks a generics safety operation
Generic portfolios create a specific kind of pressure. The individual cases are often straightforward — listed, non-serious events on well-characterised molecules — but there are a great many of them, spread across a product-by-market matrix that multiplies faster than headcount can follow.
Cost per case is the binding constraint
With thin per-product margins, the economics of safety are decided by how much manual handling each case requires. A licence model priced per seat rather than aligned to volume works directly against that.
The obligation matrix multiplies
Forty products across a dozen markets is not fifty-two decisions — it is a matrix. Which authority, which format, which timeline, against which datasheet, is a combinatorial problem that people cannot hold reliably in their heads.
A datasheet per product, per market
Listedness is assessed against the reference safety information for that product in that market. Keeping dozens of documents version-controlled and effective-dated is where audit findings concentrate.
Literature monitoring across many actives
The literature obligation is per active substance. A portfolio of thirty molecules means thirty search strategies producing thousands of hits per cycle, of which a handful are reportable.
A periodic report calendar that never empties
PSUR and PADER cycles across a large portfolio mean a data lock point somewhere most months. Assembling listings and tabulations manually each time is a permanent tax on senior time.
Manual effort spent on genuinely low-risk cases
When most of the volume is listed, non-serious events on established profiles, processing every one at the same depth as a serious unlisted case allocates your most expensive attention to the least risky work.
PVgenix attacks the volume directly: AI-assisted extraction and coding with per-field confidence scoring removes the data entry, configurable straight-through processing handles qualifying low-risk case types under thresholds you set, and the reporting rules engine resolves the product-by-market obligation matrix automatically — so human review is concentrated where risk actually sits.
What changes at volume
The capabilities below are the ones whose value compounds with case count and portfolio breadth.
AI extraction across high inbound volume
Case data extracted from PDFs, emails, and narratives with domain-segmented extraction and per-field confidence scoring, so the keystrokes that scale linearly with volume largely disappear.
See how it worksStraight-through processing, scoped
Configurable straight-through processing applied only to qualifying, low-risk case types, with thresholds set per product and case type. Human review remains the default for serious or low-confidence cases.
See how it worksAuto-coding with override
MedDRA and WHO Drug Dictionary auto-coding against admin-controlled dictionary versions, with manual override recorded — the coding load is where volume hurts most.
See how it worksRules engine for the product-by-market matrix
Configurable reporting rules resolve destination, format, and deadline from case attributes per product and per market, with Day 0 determined automatically — so adding a market is configuration, not retraining.
See how it worksPer-product reference safety information
Version-controlled CCDS/CCSI, SmPC, and USPI per product with effective dates, so a listedness call across a large portfolio is always traceable to the right document version.
See how it worksLiterature monitoring at portfolio scale
Scheduled searches per active substance with automated screening, duplicate and previously-reviewed detection, and AI-flagged candidate ICSRs confirmed by a reviewer — thousands of hits reduced to a reviewable few.
See how it worksScheduled aggregate reporting
PBRER/PSUR and PADER generation scheduled to data lock points across the portfolio, with line listings and tabulations produced from one interval query per cycle rather than assembled by hand.
See how it worksSignal detection where volume supports it
PRR, ROR, BCPNN/IC, and EBGM with masking detection and configurable thresholds — disproportionality statistics are most meaningful precisely at the case volumes a generics portfolio generates.
See how it worksWhy the economics work at volume
For a generics operation the question is not whether the platform can process a case — it is what each case costs to process and what happens when the portfolio doubles.
Cost follows need, not headcount
No heavy per-seat enterprise licensing and an efficient hosting footprint, so the cost base does not step up every time you add a processor to keep pace with volume.
You decide where automation stops
Straight-through processing scope, confidence thresholds, and mandatory review gates are configured per product and case type by your team — so the level of automation is a documented client decision you can defend at inspection.
Adding a market or product is configuration
New products, markets, code-list values, datasheets, and reporting rules are administered from the admin console without a release — the difference between a growing portfolio being routine and being a project each time.
Review effort concentrated on real risk
Per-field confidence scoring routes uncertain items to humans and lets straightforward listed non-serious cases move efficiently, so your senior reviewers spend their time on serious and unlisted cases.
Compliance metrics computed, not compiled
On-time submission rate derived from the submission records themselves, with overdue and at-risk queues surfaced before deadlines pass — which matters more as the number of concurrent obligations grows.
Reconciliation for partner and distributor flows
Licence-partner case reconciliation with discrepancy tracking — relevant for generics portfolios distributed through partners in multiple territories, and a frequent inspection finding when neglected.
Answers before the demo
The questions that come up in most evaluations. If yours is not here, ask it on the call.
Browse the full FAQIt is designed for it. The architecture is cloud-native and scales with case volume rather than requiring a step change in infrastructure, and the features that matter at volume are the automation ones: AI-assisted extraction with per-field confidence scoring, auto-coding against admin-controlled dictionary versions, configurable straight-through processing for qualifying low-risk case types, and a rules engine that resolves reporting obligations automatically. Discuss your expected annual volume with us so the deployment and commercial model are sized against real numbers.
Straight-through processing allows a case to move through the workflow with reduced manual intervention. In PVgenix it is configurable and applied only to qualifying, low-risk case types, with thresholds set per product and case type by your team. Human review remains available throughout and is the default for serious or low-confidence cases. It suits generics portfolios because a higher proportion of the volume is listed, non-serious events on well-characterised molecules — but the scope is your documented decision, not a system default, and you should be able to justify it at inspection.
Through a configurable reporting rules engine rather than institutional memory. Rules resolve which authority receives which case, in which format, within which timeline, from case attributes including seriousness, expectedness, market, and study versus spontaneous source — configured per product and per market. Reference safety information is version-controlled per product with effective dates, and code lists and picklists are administered centrally, so adding a market or a product is a configuration task.
Yes. Scheduled searches run per active substance against databases such as PubMed/MEDLINE and Embase plus local journals, with automated relevance screening, duplicate and previously-reviewed article detection, and AI-flagged candidate ICSRs presented to a qualified reviewer for confirmation against the ICH E2D criteria. The audit trail records the search strategy, screening decisions, and reviewer sign-off per cycle.
Yes. Aggregate reporting supports PBRER/PSUR and PADER with scheduled generation aligned to data lock points, plus ad-hoc generation. Line listings and cumulative and interval summary tabulations are produced from a single interval query per cycle, with every figure traceable to the case versions included at lock. Authoring and interpretation remain with your qualified PV personnel.
Disproportionality statistics are most meaningful where case volume supports them, which is often true of generics portfolios even where individual products are well characterised. PVgenix provides PRR, ROR, BCPNN/IC, and EBGM with masking detection, configurable thresholds, and signal lifecycle management. Masking detection matters particularly in a broad portfolio, where a high-frequency event on one product can obscure a genuine signal on another.
Pricing is quoted per engagement based on deployment model, portfolio and market scope, case volume, and the capability scope agreed. The relevant structural points are that there is no heavy per-seat enterprise licensing and the hosting footprint is efficient, so the cost base does not step up each time headcount grows to meet volume. Note that MedDRA and WHO Drug Dictionary licences are procured by you and should be budgeted separately.
See the numbers on your case volume
Request a 30-minute demo and we will walk through extraction, straight-through processing scope, and the product-by-market rules matrix on your portfolio.