Periodic reports built from the case data you already hold
Generate DSUR, PBRER/PSUR, and PADER outputs from the same case records your team processes every day — with line listings and summary tabulations produced from one interval query, and every figure traceable back to the cases behind it.
The periodic obligations, on the data you already process
Aggregate reports are not a separate dataset. Each one is a defined slice of the same case population your team works in daily — scoped by product, study, market, and interval, with the selection logic held in the platform rather than in someone's query.
Annual safety reporting across a development programme, built from clinical-trial cases with study and protocol context already on the record.
- Study-scoped case selection
- Cumulative and interval views
- SUSAR line listings
Periodic benefit-risk reporting for authorised products, drawing on post-marketing cases, listedness status, and the reference safety information in force.
- Interval and cumulative tabulations
- Listedness-aware selection
- Appendix-ready outputs
Periodic reporting for the US market, with the same interval case population and traceability as the rest of your reporting cycle.
- US-market case scoping
- Quarterly / annual intervals
- Consistent selection logic
One interval query. Every output in the cycle.
The expensive part of a periodic report is usually not the writing — it is assembling consistent numbers. PVgenix resolves the interval population once at the data lock point, then produces the listings, the tabulations, and the section figures from that single selection, so nothing disagrees with anything else.
Resolved once at the data lock point — scoped by product, study, market, and interval, at the case versions in force on that date.
Case-level listings for the interval population, formatted for appendix assembly.
Cumulative and interval counts by system organ class and preferred term.
The counts, exposures, and case figures the authored report sections reference.
Partner, sponsor, and authority data requests served from the same selection logic.
| System organ class | Preferred term | Interval | Cumulative |
|---|---|---|---|
| Hepatobiliary disorders | Cholestatic hepatitis | 4 | 17 |
| Hepatobiliary disorders | Hepatic enzyme increased | 9 | 41 |
| Nervous system disorders | Headache | 22 | 138 |
| Skin disorders | Rash maculo-papular | 6 | 29 |
Every number in the report traces back to a case
The question that follows a periodic report is always the same: where did this figure come from? Because outputs are generated from the frozen interval population rather than assembled by hand, the answer is a drill-down — not an archaeology exercise through old spreadsheets.
The interval population records which case version was included, so regenerating the same report yields the same numbers.
Each generation and regeneration is logged with its parameters, its owner, and its timestamp.
Route report outputs through safety reviewer and QPPV sign-off, configured to your SOPs.
Partner and clinical-database reconciliation runs before the lock point, so discrepancies are resolved rather than reported.
PVgenix produces the data, the listings, and the tabulations. The medical writing and benefit-risk interpretation in a periodic report remain with your qualified PV personnel.
What aggregate reporting covers
The full capability set for periodic and ad-hoc aggregate reporting.
Report types supported
- DSUR — Development Safety Update Report for interventional studies
- PBRER / PSUR — Periodic Benefit-Risk Evaluation Report and Periodic Safety Update Report for marketed products
- PADER — periodic reporting for the US market
- Ad-hoc safety data outputs for partner, sponsor, or authority requests
Line listings & summary tabulations
- Line listings generated from the interval case population
- Cumulative and interval summary tabulations by SOC and preferred term
- Consistent case selection logic applied across every output in a reporting cycle
- Drill-down from any figure to the underlying case records
- Configurable output formats for authoring and appendix assembly
Scheduling & data reuse
- Scheduled generation aligned to data lock points and report due dates
- Ad-hoc generation for interim reviews and partner requests
- Data reuse across reporting outputs — one interval query feeds listings, tabulations, and section data
- Reporting outputs versioned and retained with the report record
- Reconciliation support against clinical and partner data sources before a data lock point
Traceability & sign-off
- Every tabulated figure traceable to the case versions included at data lock
- Audit trail of report generation, regeneration, and parameter changes
- Configurable review and approval workflow for QPPV and safety reviewer sign-off
- Generated outputs stored with version control and role-based access control
See a reporting cycle run on your data
Request a demo to see a data lock point, an interval case population, and the line listings and summary tabulations generated from it.