CompoundYour signals satisfied.
Your submissions on time.
Compound ingests 1.2M adverse event cases and surfaces PRR, ROR, and BCPNN signals in 14 seconds — with 21 CFR Part 11-compliant exports ready before your next quarterly FDA submission deadline.
QT Prolongation [10035473]
ICSR · FAERS Q4-2025
Hepatotoxicity [10019851]
Literature · PubMed PMC11234
Rhabdomyolysis [10039020]
EHR · EHR-Network US-West
Stevens-Johnson [10042033]
ICSR · EUDRAVIGILANCE
Aplastic Anaemia [10002272]
RWD · Claims DB — Optum
Hypotension [10021097]
ICSR · FAERS Q4-2025
Renal Impairment [10038435]
Literature · Cochrane SR-2025
Dyspnoea [10013968]
EHR · EHR-Network EU-Central
QT Prolongation [10035473]
ICSR · FAERS Q4-2025
Hepatotoxicity [10019851]
Literature · PubMed PMC11234
Rhabdomyolysis [10039020]
EHR · EHR-Network US-West
Stevens-Johnson [10042033]
ICSR · EUDRAVIGILANCE
Aplastic Anaemia [10002272]
RWD · Claims DB — Optum
Hypotension [10021097]
ICSR · FAERS Q4-2025
Renal Impairment [10038435]
Literature · Cochrane SR-2025
Dyspnoea [10013968]
EHR · EHR-Network EU-Central
median signal detection — across 1.2M adverse event cases
Supported Detection Methods
Proportional Reporting Ratio (PRR)
Compares the proportion of a specific AE for a drug against all other drugs in the database.
PRR ≥ 2, χ² ≥ 4, N ≥ 3Signal score + 95% CIReporting Odds Ratio (ROR)
Case/non-case methodology from spontaneous reporting systems with logistic regression correction.
Lower bound CI > 1ROR + confidence intervalBCPNN (IC Method)
Bayesian Confidence Propagation Neural Network — the WHO Uppsala Monitoring Centre standard.
IC025 > 0Information Component (IC)EBGM (Empirical Bayes)
Multi-item gamma Poisson shrinkage estimator used by FDA AERS database analysis.
EBGM05 ≥ 2Geometric mean + EB05Technical Specifications
| Parameter | Specification |
|---|---|
| Input sources | FAERS, EUDRAVIGILANCE, VIGIBASE, EHR, Literature, RWD, E2B(R3) XML |
| Median detection time | 14 seconds (p50 across 1.2M case corpus) |
| Accuracy vs manual review | 95.3% concordance (n=12,400 validated signals) |
| Throughput | 300× faster than manual disproportionality analysis |
| MedDRA version support | MedDRA 26.1 (current) — auto-updated quarterly |
| Minimum viable dataset | N ≥ 3 cases, any reporting period |
| Multilingual NLP | 34 languages, WHO ICD-10 cross-mapping included |
| Output format | Signal list JSON, CIOMS I XML, E2B(R3), CSV, PDF |
compliant out of the box — no custom validation required
Export Format Matrix
| Format | Authority | Use Case | Status |
|---|---|---|---|
E2B(R3) XML | ICH / FDA / EMA | Individual Case Safety Reports | ● Native |
PSUR / PBRER | EMA / MHRA | Periodic Safety Update Reports | ● Native |
PADER | FDA | Periodic Adverse Drug Experience Reports | ● Native |
DSUR | ICH E2F | Development Safety Update Reports | ● Native |
CIOMS I | CIOMS | Expedited safety reports | ● Native |
MedWatch 3500A | FDA | 15-day expedited reports | ● Native |
HL7 FHIR R4 | HL7 | Interoperability exchange | ◐ Beta |
CDISC SEND | CDISC | Nonclinical study data | ● Native |
Regulatory Compliance Coverage
Audit-defensible signal narratives
Every export includes a machine-generated signal narrative with full methodology citation, statistical rationale, and data lineage trace — structured to satisfy FDA Information Request responses and EMA Day 120 list queries without additional manual documentation.
certified source integrations — FAERS to EHR to claims in one pipeline
Source Connector Library
Ingestion Specifications
| Parameter | Specification |
|---|---|
| Supported input formats | E2B(R3) XML, CSV, JSON, HL7 FHIR R4, CDISC SEND, PDF (OCR), XLSX |
| Source connectors | 47 certified connectors across regulatory DBs, EHRs, and RWD sources |
| Ingestion throughput | 1.2M cases / 14 seconds (batch); real-time streaming at 8,000 events/min |
| NLP languages | 34 languages with WHO ICD-10 cross-mapping and MedDRA auto-coding |
| Deduplication | Probabilistic matching (Jaro-Winkler + phonetic) — 99.1% dedup accuracy |
| Federated learning | Cross-site model training without data egress — GDPR / HIPAA safe harbor |
| Data residency | US (AWS us-east-1 / us-west-2), EU (Frankfurt), UK (London), JP (Tokyo) |
| SLA uptime | 99.95% guaranteed (contractual) · Sub-30s ingest latency for streaming |
Federated learning architecture
Compound's federated model trains across your network, partner CROs, and public regulatory databases without any patient-level data leaving your environment. Compliant with GDPR Article 25 (data protection by design) and HIPAA Safe Harbor de-identification standards.
electronic audit trail — every action hashed, timestamped, and signed
Audit Log Sample — Session 8847
2026-02-27 21:04:01 UTC[sarah.chen@pharma.co]Signal run initiated→ FAERS Q4-2025 · 1,247,834 casessha256:a3f9...c7e22026-02-27 21:04:15 UTC[system/compound-engine]PRR analysis completed→ 4 signals above threshold (PRR ≥ 2, N ≥ 3)sha256:b8d1...f4a92026-02-27 21:04:16 UTC[system/compound-engine]BCPNN IC calculated→ IC025 > 0 confirmed for 3 signalssha256:c2e7...8b3d2026-02-27 21:04:18 UTC[sarah.chen@pharma.co]Signal review — approved→ Rhabdomyolysis · MedDRA 10039020sha256:d5f3...2c8e2026-02-27 21:04:22 UTC[raj.mehta@pharma.co]PSUR export generated→ PSUR-2026-Q4-v1.xml · E2B(R3) formatsha256:e9a4...7d1fValidation Specifications
| Parameter | Specification |
|---|---|
| Audit trail coverage | 100% of user actions, system events, and data transformations |
| Immutability | SHA-256 hash chain — tamper-evident, WORM-compliant storage |
| Electronic signatures | 21 CFR Part 11.50 compliant — meaning, date, time, user ID |
| Retention period | Configurable — default 10 years (exceeds FDA NDA requirement) |
| Validation package | IQ/OQ/PQ documentation included — GxP validated out of the box |
| Change control | SOP-driven versioning with impact assessment and re-validation triggers |
| Audit export format | PDF/A-3, XML, CSV — directly submittable to FDA inspectors |
| Explainability (XAI) | SHAP values + LIME explanations for every AI signal recommendation |
+ GxP validated + ISO 27001 — across all three deployment models
Deployment Options
SaaS (Multi-tenant)
Production-ready in 4 hours. Hosted on SOC 2 Type II certified infrastructure.
- AWS GovCloud eligible
- Auto-scaling compute
- Daily backups (30-day retention)
- Managed updates
Single-tenant Cloud
Dedicated infrastructure in your preferred cloud region. Data never leaves your account.
- AWS / Azure / GCP
- VPC isolation
- Bring your own KMS keys
- Custom SLAs available
On-Premise / Air-gap
Fully self-hosted deployment for regulated environments requiring no external connectivity.
- Kubernetes / Docker
- No outbound network required
- HSM key management
- GxP deployment guide
Certifications & Compliance
Your signals, satisfied.
Your next submission, on time.
Run a live signal detection pilot against your own anonymized FAERS extract. Compound's solutions engineers configure the environment, load your data, and walk you through the results — no IT involvement, no long-form contract.
No contract · No credit card · 1-day setup