Case studies / Aggregate reports
Illustrative case study · Aggregate reports
Halving the time from data lock to first PBRER draft
How a mid-size pharma company used vGenix Ai aggregate reports, from baseline to results.
OrganisationMid-size pharma company
RegionEU and US
Reports30 PBRERs and PADERs a year
ScopeAggregate reports
Results at a glance
What changed
−50%Data lock to first draft6 → 3 weeks
100%Statements traced to sourceEvery figure linked
-50%Review rounds per reportAs per clients SOP
100%On-time submissionAs per clients SOP
The challenge
Where they started
- PBRERs built from several data exports reconciled by hand
- Tables and line listings formatted manually
- Inconsistencies found late in review
- Six weeks from data lock to first draft
The solution
What they deployed
- Reporting calendar tracking every obligation and data lock
- One verified, versioned dataset at data lock
- Tables, listings and supporting narratives drafted in house style
- Section owners, approvals and QPPV e-signature built in
Implementation
How it was rolled out
Month 1
Scope and templates
Report types, templates and section owners agreed.
Month 2
Configure and validate
Data lock, tables and drafting configured and tested.
Month 3
First live report
First PBRER produced alongside the old process.
Month 4 onward
Steady state
All periodic reports produced on the platform.
Before and after
Measured against the agreed baseline
| Measure | Before (baseline) | After |
|---|---|---|
| Data lock to first draft | 6 weeks | 3 weeks |
| Manual data reconciliation | Every report | None |
| Consistency findings in QC | Hard to trace | Traceable |
| Review rounds | Multiple | Very few |
Illustrative figures. In a real engagement, baselines are agreed before go-live and results measured from platform data.
Next step
Get results like these on your data
We agree the baseline with you, run a pilot on your own data, and report the results.
Recommended
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one