Function · Pharmacovigilance
Aggregate reports, reconciled cycle over cycle.
SyncIQ drafts your aggregate safety reports against your own safety database, shows what changed since the last cycle, and writes case narratives from the case record.
The periodic reports run on a fixed calendar. Signal work does not. Two clocks, two applications.
The work
Two clocks that don't line up.
01
A calendar fixed years in advance
PBRERs, PSURs, PADERs and DSURs fall due on dates set by the EU reference date list and the approval record — not by how much work the period actually produced.
PSUR within 70 days of the data lock point. PADER quarterly for three years. India six-monthly, then yearly.
02
A case stream that never pauses for it
Cases arrive with their own deadlines. Literature has to be screened, EudraVigilance monitored, and every validated signal evaluated — and the write-up usually happens after the decision is taken.
Literature screened weekly at minimum. ICSRs on 7, 15 and 90-day clocks.
Capabilities
What SyncIQ does.
PBRERs written against your safety database
SyncIQ drafts the report from the safety database and your product record, to your current template and the nineteen-section format, with every figure carrying the query behind it.
What changed since the last cycle
The draft states the differences from the prior period with the data behind them, so the comparison stops being a manual pass through two documents.
PADERs and DSURs off the same engine
US periodic reporting and development safety reporting drafted with the same reconciliation — the formats differ, the numbers underneath don't.
Counts reconciled across the portfolio
Case counts and line listings checked against each other across products, so a discrepancy shows up before an assessor finds it.
Narratives written from the case record
Written from the structured case and its source documents, each statement traceable, in one house style however many the cycle needs.
A record of what was screened
SyncIQ reviews published literature and public safety data continuously, and records what was searched, when, and what was excluded.
Signal evaluations documented as you work
The evaluation gets written while the evidence is being weighed rather than reconstructed afterwards, with the evidence considered attached — and risk management plans kept current against the safety profile they describe.
Evidence
What the calendar requires.
The obligations are fixed and the volume isn't. FAERS took in more than two million case reports in 2025, against 781,619 in 2011, and the reporting schedule those cases feed hasn't moved.
In MHRA good pharmacovigilance practice inspections the recurring findings are the documentation ones — signal management, ongoing safety evaluation, and the quality system around them, with delays in completing signal evaluations named specifically.
- 2M+
- case reports into FAERS in 2025, against 781,619 in 2011FDA
- Weekly
- minimum frequency for systematic review of the medical literatureEU GVP Module VI
- 70 days
- from data lock point to PSUR submission, for intervals up to twelve monthsEU
The first two are minimum frequencies set by regulation. The third is the volume they have to absorb.
The applications
Two applications, one safety record.
The calendar and the case stream need different things: one needs reconciliation against the last cycle, the other needs the write-up done while the work is happening.
The fixed calendar
Aggregate Safety
PBRERs, PSURs, PADERs and DSURs
The portfolio grows, the headcount doesn't, and every cycle somebody compares this report against the last one by hand. Aggregate Safety drafts the PBRER against the safety database and reconciles it to the prior cycle, with the differences already surfaced.
See Aggregate Safety
The continuous stream
Signal Desk
Case narratives, literature screening and signal evaluation
Screening is continuous, the evidence is scattered, and the documentation gets written after the decision. Signal Desk writes narratives from the case record at volume and documents the evaluation as the work happens, not six weeks later.
See Signal Desk
Both read and write the same safety record, on one audit trail and one security model. So the case that produced a narrative in March is the case the PBRER counts in September, and the signal evaluation that followed points back to both.
Accountability
The obligation stays with the marketing authorisation holder.
EMA's 2024 reflection paper on AI across the medicinal product lifecycle names pharmacovigilance directly, including adverse event report management and signal detection. It is equally direct about responsibility: the marketing authorisation holder validates, monitors and documents model performance, and folds those operations into its pharmacovigilance system. EMA and the heads of agencies add that using large language models needs human oversight and traceable decision logic.
SyncIQ works that way by design. Every statement in a draft links to the record it came from, every run is auditable, and the assessment stays with your safety physician.
21 CFR Part 11-aware. Your cloud, your data residency, full audit trail, and your data never trains foundation models.
Security & deploymentCoverage
What's covered, and the standards behind it.
Aggregate safety reporting, case narratives, literature screening, signal evaluation and risk management plans. Written against ICH E2C(R2) for the PBRER, ICH E2F for the DSUR, EU good pharmacovigilance practice, 21 CFR 314.80 for US periodic reporting, and the Indian requirements under the New Drugs and Clinical Trials Rules.
What lands on your desk
- PBRERs drafted against the safety database and checked against last period
- PSURs where the region still wants that format, PADERs for the US
- DSURs across the development programme
- Case narratives written from the case record, at volume
- Signal evaluation reports
- Risk management plans
- Literature screening with the documentation behind it
One report, three formats
PBRER is ICH E2C(R2) and has largely replaced PSUR in the EU and UK. FDA accepts a PBRER in lieu of a PADER. CDSCO still wants PSURs for the first four years post-approval, which matters for the Indian portfolio.
The Indian clock
Six-monthly for the first two years and yearly for the next two, each within thirty days of the period closing. And since April 2026 the clock starts from the date the drug is actually marketed rather than the date it was approved, so a delayed launch no longer shortens the reporting history.
Working on something in safety that you don't see here? Tell us the work that'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.