Platform / Aggregate reports
Aggregate reports in weeks, not months
Compile PSURs, PBRERs, DSURs and PADERs from one verified dataset, with narratives and tables drafted in your house style and every statement traced to its source.
Every obligation and due date
Every draft kept
Everything aggregate reports needs, in one place
Reporting calendar
Every periodic report is tracked by product, jurisdiction and obligation, with data lock points and due dates, so preparation starts on time.
- PSUR, PBRER, DSUR and PADER obligations
- Data lock points and due dates calculated
- Upcoming reports surfaced weeks ahead
- Powered by Regulatory Intelligence
| Report | Product | Data lock | Due | Status |
|---|---|---|---|---|
| PBRER | Product [A] | [date] | [date] | Drafting |
| DSUR | Product [B] | [date] | [date] | Planned |
| PADER | Product [C] | [date] | [date] | Planned |
One verified dataset
At data lock, cases, literature and signals are combined into one verified, version-controlled dataset, so every table and statement comes from the same numbers.
- Cases, literature and signals combined
- Reconciliation checks before lock
- Exposure data added from your sources
- Dataset frozen and versioned at lock
Drafted in your style
Tables, line listings and narrative sections are drafted from the locked dataset using your templates and house style, ready for expert review.
- Summary tabulations and line listings generated
- Narrative sections drafted from the evidence
- Your templates, headings and style
- Every draft section editable by your team
Traceable statements
Every figure and statement in the report links back to the data it came from, so reviewers and assessors can check anything in seconds.
- Every figure linked to the dataset
- Every statement linked to its evidence
- Consistency checked across sections
- Links kept in the final version history
Collaborative review
Each section goes to the right expert for review and approval, with comments, versions and sign-offs tracked in one place.
- Section owners assigned per report
- Comments and changes tracked
- Approvals and e-signatures recorded
- QPPV sign-off before finalisation
Ready to submit
The approved report is assembled into its final form, with every version kept, ready for submission through regulatory submission.
- Final document assembled from approved sections
- Version history kept
- Submission tracked against the due date
- Archived with its dataset and approvals
Four steps, one continuous flow
Plan
Obligations and timelines
Data lock
One verified dataset
Draft
Tables and narratives
Approve
Expert review and sign-off
AI does the work. Your experts decide.
- Tracking obligations and due dates
- Compiling data at data lock
- Generating tables and line listings
- Drafting narratives
- Checking consistency across sections
- Assembling the final document
in the
loop
- Benefit–risk evaluation
- Reviewing each section
- Interpreting signals
- Approving conclusions
- QPPV sign-off
- Responding to agency questions
vGenix Ai vs other approaches
How aggregate reports works today in most teams, with point tools, and with vGenix Ai.
| Area | Manual process | Point-tool automation | vGenix Ai |
|---|---|---|---|
| Planning | Calendar in spreadsheets | Separate tracker | Every obligation, data lock and due date tracked |
| Data | Pulled from several systems | Exports reconciled by hand | One verified dataset, locked and versioned |
| Tables and listings | Built manually | Generated, then reformatted | Generated in your templates |
| Narratives | Written from scratch | Generic text generation | Drafted from the evidence in your house style |
| Consistency | Checked by reviewers | Not checked across sections | Figures and statements checked across sections |
| Traceability | Manual references | Partial | Every statement linked to its source |
| Review | Email and tracked changes | Document tool | Section owners, approvals and e-signatures built in |
“Point-tool automation” describes separate tools that each automate one step. It does not refer to any named vendor.
What changes, and how we measure it
Every engagement starts with your baseline. These are the measures we track for aggregate reports.
Illustrative scenario: a mid-size pharma company handling about 40,000 ICSRs a year across 3 regions. These figures are for discussion, not client results. In every engagement we agree baselines with you before go-live and measure results from platform data.
- Data lock to first draft
- Total report cycle time
- Review rounds per report
- On-time submission rate
- Consistency findings in QC
Part of one platform
Aggregate reports shares its data model, rules and audit trail with every other module, so nothing is re-keyed between them.
Intelligent safety should be one connected operation
Automate the work. Keep the decisions with your experts. Keep the evidence traceable. See it on your own data in six weeks.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one