The regulatory clock, the rules, and the gateway built in
Determine Day 0 automatically, let a configurable rules engine decide which authority receives which case in which format, generate E2B(R2)/E2B(R3) and form outputs, and transmit through a built-in AS2 gateway — with acknowledgements reconciled back to the case.
One case in. Every obligation, deadline, and destination out.
Reportability is not a single answer — the same case can create several obligations in different formats on different clocks. The rules engine resolves them all from the case attributes, sets Day 0, and tracks each deadline separately.
Day 0 is derived from the receipt date per reporter region, not entered by hand.
Rules are configured per tenant, market, and study — no code change to add an obligation.
Each obligation carries its own deadline and owner, tracked independently.
At-risk and overdue submissions escalate to the responsible owner before the deadline passes.
Generated, checked, transmitted, reconciled
A submission is not finished when the file leaves the building. PVgenix closes the loop — schema and business-rule checks before transmission, and acknowledgement parsing that ties the outcome back to the case that produced it.
Generate
E2B(R2) or E2B(R3) XML is generated from the approved case version, in the profile the receiving authority expects.
E2B(R2) · E2B(R3)Check
Schema and business-rule checks run before anything leaves the system, so structural rejections are caught in-house.
schema + business rulesTransmit
The built-in AS2 gateway handles the transmission — no third-party gateway licence to procure or maintain.
built-in AS2Reconcile
Acknowledgements are parsed and matched back to the case; failures raise a retransmission task rather than going unnoticed.
ACK reconciliationNo third-party gateway licence to buy
Gateway software is usually a separate product with its own licence, its own qualification, and its own vendor relationship. PVgenix ships the AS2 gateway inside the platform, so transmission is part of the same system — and the same audit trail — as the case that produced the file.
Generation, transmission, and acknowledgement events are recorded against the case record.
Corrected and withdrawn reports are handled as first-class flows, not manual workarounds.
One less integrated third-party component in scope for your qualification effort.
The on-time submission number, without a spreadsheet
On-time submission rate is the compliance KPI a CRO reports to each sponsor every month, and the number an inspector asks about first. PVgenix computes it from the submission records themselves — per sponsor, per tenant, per authority — rather than from a manually maintained tracker.
Each sponsor sees their own on-time metrics, scoped by tenant, with no cross-client leakage.
Submissions approaching or past their deadline are surfaced as a working queue with an accountable owner.
Every generation, transmission, and acknowledgement event is time-stamped and attributable.
On-time submission rate · rolling 30 days
Queues
What regulatory submission and exchange covers
The full capability set for the submission and exchange stage of the ICSR lifecycle.
Regulatory clock & rules engine
- Automatic Day 0 determination and expedited timeline calculation (e.g. 7-day and 15-day) per reporter region
- Due-date tracking with late-submission alerts before the clock runs out
- Configurable reporting rules deciding which authority receives which case, in which format, within which timeline
- Rules driven by case attributes — seriousness, expectedness, market, and study versus spontaneous source
- Study-specific and market-specific rule sets per tenant
E2B generation & exchange
- E2B(R2) and E2B(R3) XML generation with schema and business-rule checks before transmission
- Built-in AS2 gateway — no external gateway license required
- Regulatory authority coverage including FDA (FAERS / ESG gateway), EMA (EudraVigilance), and MHRA submission support
- Acknowledgement (ACK) handling with reconciliation back to the source case
- Retransmission and nullification handling for corrected or withdrawn reports
Form outputs & documents
- CIOMS I form generation
- FDA MedWatch (3500A) form generation
- Generated submission documents attached to the case record with version control
- Secure document access tied to role-based access control
Submission tracking & compliance metrics
- Submission tracking dashboard with real-time on-time submission metrics
- Per-sponsor and per-tenant compliance reporting — the KPIs CROs report monthly
- Overdue and at-risk submission queues surfaced to the responsible owner
- Full audit trail of every generation, transmission, and acknowledgement event
See your reporting obligations resolved end to end
Request a demo to see Day 0 determination, your rule set, E2B generation, AS2 transmission, and acknowledgement reconciliation on a live case.