Function · Pharmacovigilance
Safety writing, from PBRERs to signal evaluations.
SyncIQ drafts aggregate safety reports against your safety database, reconciled to the last cycle. It also writes case narratives and documents signal evaluations.
Periodic reports run on a fixed calendar. Signal work does not. Two applications, one for each.
The work
Two clocks that don't line up.
01
A reporting calendar set in advance
PBRERs, PSURs, PADERs and DSURs fall due on dates set by the EURD list, the approval or launch date, and, for DSURs, the first trial authorization.
PADER quarterly for three years, then annually.
02
A signal workload that never pauses
Literature and public safety data are screened continuously, and each validated signal is assessed. The write-up can trail the decision.
Capabilities
What SyncIQ does.
PBRERs and PSURs to ICH E2C(R2)
Drafted from your safety database and product record, to your current template.
What changed since the last cycle
Each draft is reconciled to the prior cycle, with what changed surfaced alongside the data behind it.
PADERs and DSURs on the same engine
Periodic adverse drug experience reports (PADERs) and DSURs drafted on the same engine, with the same reconciliation.
Counts reconciled across the portfolio
Case counts and line listings checked against each other across your products.
Case narratives from the case record
Safety narratives written from the structured case and its source documents, each statement traceable, in one house style.
A record of what was screened
Published literature and public safety data screened continuously, with what was reviewed recorded.
Signal evaluations and risk management plans
Signal evaluation documented as the work happens, evidence attached. Risk management plans drafted and kept current.
Evidence
What regulators require.
MHRA's GPvP inspection findings for 2016 to 2023 put risk management, ongoing safety evaluation (signals included) and the quality management system among the most-cited areas.
- Weekly
- minimum frequency for a systematic literature reviewEU GVP Module VI
- 70 days
- calendar days from data lock point to PSUR submission, for intervals up to 12 monthsEU GVP Module VII
The applications
Two applications, one safety record.
The fixed calendar
Aggregate Safety
PBRERs, PSURs, PADERs and DSURs
Aggregate Safety drafts aggregate safety reports against the safety database and reconciles each to the prior cycle, PADERs and DSURs included.
See Aggregate Safety
The continuous stream
Signal Desk
Narratives, literature screening, signal evaluation and RMPs
Signal Desk writes case narratives, screens literature continuously, documents signal evaluation as it happens and keeps risk management plans current.
See Signal Desk
Both work from the same safety database, so the case behind a March narrative is the case the September PBRER counts.
Accountability
AI in pharmacovigilance stays the MAH's responsibility.
EMA's 2024 reflection paper on AI names pharmacovigilance directly and states that validating, monitoring and documenting model performance remains the marketing authorization holder's responsibility.
Drafts link to the records they came from, every run is auditable, and the assessment stays with your safety physician.
Security & deploymentCoverage
What's covered, and the standards behind it.
Written against ICH E2C(R2) for the PBRER, ICH E2F for the DSUR, EU good pharmacovigilance practice, 21 CFR 314.80 and India's New Drugs and Clinical Trials Rules.
What lands on your desk
- PBRERs drafted and reconciled to the prior cycle
- PSURs where required, PADERs for the US
- DSURs across the development program
- Safety narratives written from the case record
- Signal evaluation reports
- Risk management plans, drafted and kept current
- Literature screening, with what was reviewed recorded
One report, three formats
PBRER is the ICH E2C(R2) format, and EU and UK PSURs follow it; EU PSURs on the EURD list are assessed through PSUSA. FDA accepts a PBRER in place of a PADER under a waiver.
The Indian clock
CDSCO wants PSURs six-monthly for two years, then yearly for two, each within thirty days of the period closing. Where launch follows approval, the clock starts at launch, as CDSCO's April 2026 advisory confirmed.
Something in safety you don't see here? Tell us what's slowing you down →
Start where it hurts.
We'll run it live on one of your own cycles, against your own safety data.
Request a demoYour data stays in your environment. Customer data never trains foundation models.