Drug safety · Quandra v8
Pharmacovigilance software with verified signal detection
Most AI tools will happily tell you a Reporting Odds Ratio and get it wrong. Quandra computes disproportionality statistics with a deterministic solver, checks every number before it is shown, cites a versioned regulatory corpus, and records who signed off. Built for small and mid-sized biotech safety teams that need a defensible answer, not a confident one.
What the pharmacovigilance module does
Disproportionality analysis
PRR, ROR with 95% confidence intervals, chi-square with Yates correction, IC025, and EBGM/EB05 computed by a deterministic solver — not generated as text by a language model.
Verified signal detection
Every threshold call is re-derived and re-checked before it is shown. Signals are flagged against the criteria you specify (for example PRR ≥ 2 with n ≥ 3 and chi-square ≥ 4), and the arithmetic is displayed alongside the verdict.
Citations to a versioned corpus
Regulatory statements are tied to a locked reference corpus including 21 CFR reporting requirements and ICH E2 guidance, pinned by version so the same question returns the same citation next quarter.
Audit-ready by construction
Tamper-evident audit records, a PHI firewall that blocks patient identifiers before they reach a model, and a two-person sign-off gate before any answer is marked final.
Where safety teams use it
Signal triage from aggregate counts
Enter the 2x2 counts for a drug–event pair and get every standard disproportionality measure at once, with the contingency table, the formula used, and which screening criteria were met or missed.
Safety narrative and reporting logic
Ask what the expedited reporting clock looks like for a given seriousness and expectedness classification, and get the answer with the governing regulatory citation attached rather than a paraphrase.
Analysis plan and SOP language
Draft the signal detection methodology section of a safety plan — thresholds, stratification, and limitations — with the statistical reasoning written down for your safety physician to review.
Reproducible code for your stack
Export runnable R or SAS that reproduces the same computation inside your validated environment, so the final numbers come from the system of record.
What it is not
Quandra is research use only. It is not a validated safety database, not a replacement for a case processing system, and not validated software under 21 CFR Part 11. It does not provide medical or regulatory advice, and it does not submit anything to a health authority. Every output is scoped as analysis and requires human review and sign-off by a qualified professional before it informs a regulated decision.
Pharmacovigilance software questions
- What is pharmacovigilance software?
- Pharmacovigilance software supports the collection, analysis, and reporting of adverse event data for a drug or biologic. It typically covers case intake, coding, disproportionality analysis for signal detection, and the documentation required for regulatory reporting.
- Which disproportionality measures does Quandra compute?
- Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR) with confidence intervals, chi-square with Yates correction, Information Component (IC/IC025), and Empirical Bayes Geometric Mean (EBGM/EB05) from a 2x2 contingency table.
- Is Quandra a validated safety database?
- No. Quandra is research-use-only decision support. It does not replace an Argus- or ArisG-class safety database, and it is not validated software under 21 CFR Part 11. Every output requires human review and sign-off before it informs a regulated decision.
- Can patient data be entered into the system?
- No. A PHI firewall blocks protected health information before it reaches any model. Signal detection runs on aggregate counts from a 2x2 table, not on individual case narratives.
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