PSUR, PBRER, DSUR — drafted, cited, ready for review.
Asthra consolidates exposure data, ICSR line listings, literature, and historical periodic reports into compliant aggregate-safety drafts — across ICH E2C and ICH E2F formats. Pharmacovigilance teams stay focused on signal evaluation, not assembly.
Whatever your reporting obligation looks like.
Periodic Safety Update Report
Marketed-product post-authorization safety. ICH E2C(R2) structure — exposure, signals, benefit-risk evaluation.
Periodic Benefit-Risk Evaluation Report
The PSUR's modern equivalent under ICH E2C(R2). Asthra writes either format from the same source set.
Development Safety Update Report
Investigational-product annual safety reporting. ICH E2F structure — clinical-trial integrated safety review.
What Asthra reads.
All structured and unstructured safety data, ingested into a single closed corpus per reporting period.
Company Core Data Sheet
Reference safety information used as the baseline for listedness assessment.
ICSR line listings
Spontaneous and clinical-trial case reports for the reporting period — by SOC, PT, seriousness, expectedness.
Exposure data
Patient-years, kilograms dispensed, treatment-days. Asthra reconciles denominators across regions and dosage forms.
Prior PSURs / PBRERs
For continuity of cumulative tables, signal-history sections, and benefit-risk narratives.
Literature search results
Embase / Medline output, screened and tagged. Asthra cites exact PMIDs and snippets in §15 literature review.
Signal-detection output
Disproportionality analyses, EBGM, ROR/PRR. Feeds §16 signal evaluation with statistical context preserved.
From data lock
to QPPV-ready draft.
Load reporting-period data (~1 hour)
Drop in line listings, exposure tables, literature output, and prior PSUR. Asthra reconciles dates, classifies sources, and confirms the data lock window.
Generate cumulative tables (~30 min)
Asthra builds the standard tabulations — cumulative ICSRs by SOC/PT, seriousness, expectedness, action taken — directly from line listings, with cell-level traceability.
Draft narrative sections (~2 hours)
§4 Estimated exposure, §6–§8 risks & effectiveness, §15 literature, §16 signal evaluation. Each narrative is generated from approved sources only.
Safety scientist review
The PV team reviews in Word — chats with Asthra to refine signal narratives, swap evidence, or pull additional cases. The reasoning behind every flag is auditable.
QPPV sign-off & submission
Final draft ships with the audit ledger embedded. The QPPV signs off; the document submits to EudraVigilance, FDA, or PMDA with a complete provenance trail.
Where the time goes — and where it goes back.
Manual PSUR drafting
- −4–8 weeks per PSUR cycle, longer for global products
- −Cumulative-tables assembly across line listings: days of work
- −Signal narratives rewritten manually each period
- −Listedness verified against the CDS line by line
- −QPPV review starts only after the full draft is assembled
PSUR drafting with Asthra
- +Draft-ready in days; review begins as sections complete
- +Tables auto-generated from line listings with cell traceability
- +Signal narratives reuse prior context, regenerated with new data
- +Listedness check applied at draft time, against the CDS
- +QPPV reviews while the data is fresh, with full provenance
Pilot Asthra
on a real PSUR.
30-day pilot. Bring one product, one reporting period. We benchmark Asthra's draft against your existing process — line listing to QPPV.