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Signal Detection

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Signal Detection

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Detect. Validate. Act—all in one platform.

Introducing our proprietary Signal Detection & Validation Tool—built in-house to give you complete control over your pharmacovigilance signal workflow. No more juggling spreadsheets, databases, and disconnected tools.

Integrated data sources: Real-time OpenFDA and MedWatch integration pulls the latest adverse event data directly into your workspace. Combine it with your internal safety database for comprehensive signal analysis.

End-to-end workflow: From initial detection through validation, prioritization, and documentation—manage everything in a single streamlined interface. Convenient import/export capabilities ensure seamless data exchange with your existing systems.

Full statistics dashboard: Visualize signal trends, PRR/ROR calculations, case distributions, and validation status at a glance. Make data-driven decisions faster with real-time analytics built for pharmacovigilance teams.

Detection Methods

Advanced Detection Methods

Data-driven signal identification. No guesswork.

Our signal detection platform employs industry-standard statistical and analytical methods to identify potential safety signals from your pharmacovigilance data:

  • Disproportionality Analysis — PRR (Proportional Reporting Ratio) and ROR (Reporting Odds Ratio) calculations to identify drug-event combinations reported more frequently than expected.
  • Bayesian Methods — EBGM (Empirical Bayes Geometric Mean) analysis for multi-item stratification and refined signal detection in large datasets.
  • Temporal Analysis — Time-to-onset patterns, trend detection, and temporal clustering to identify emerging safety concerns before they become established signals.
  • Case-Level Review — Detailed case-by-case assessment of signal-supporting cases, including causality evaluation and clinical narrative review.
  • Signal Prioritization — Automated scoring and ranking of detected signals based on clinical significance, statistical strength, and regulatory urgency.

Platform Workflow

How Our Platform Works

From raw data to regulatory action — fully integrated.

Our end-to-end signal management platform guides your safety team through every stage of the signal lifecycle:

  • 01 Data Ingestion — Import safety data from OpenFDA, MedWatch, your internal safety database, or any E2B-compatible source with automated mapping and validation.
  • 02 Statistical Screening — Automated disproportionality analysis runs against your configured thresholds, flagging drug-event combinations that warrant investigation.
  • 03 Signal Evaluation — Flagged signals reviewed against clinical context, literature evidence, and regulatory history. Each signal assessed for validity and clinical relevance.
  • 04 Validation & Documentation — Validated signals documented with full supporting evidence, statistical data, case narratives, and regulatory assessment for submission readiness.
  • 05 Signal Tracking & Reporting — Active signal tracking with dashboards, trend visualization, and automated reporting for PRAC, FDA, and internal safety committees.

Why It Matters

Why Signal Detection Matters

The signal you miss today becomes the regulatory action tomorrow.

Regulatory agencies expect Marketing Authorization Holders to conduct systematic signal detection as part of their ongoing pharmacovigilance obligations. The EMA's GVP Module IX and FDA's guidance on signal detection establish clear expectations for proactive safety monitoring.

Manual signal detection using spreadsheets and periodic reviews is no longer sufficient. Modern pharmacovigilance demands automated, reproducible, and statistically rigorous signal detection — exactly what our platform delivers.

  • Automated statistical analysis with configurable detection thresholds
  • Real-time OpenFDA and MedWatch data integration
  • Full signal lifecycle management from detection to closure
  • Audit-ready documentation for regulatory inspections
  • Intuitive dashboards for safety committee reporting

We are Drugvigil (pharmacovigilance service provider) headquartered in India. We also do our limited operations at Tbilisi, Georgia. We help pharmaceutical companies and healthcare professionals improve the safety of their products.

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