Causality Matrix - Pharmacovigilance software; Drug Safety Database

Need for this

Assessing the relationship between a drug and an adverse event is a critical part of pharmacovigilance. A structured approach is needed to determine whether a reported reaction is truly linked to the drug. Without a proper framework, decision-making becomes challenging, leading to delays in safety assessments. The Causality Matrix provides a systematic way to evaluate and classify adverse events, helping healthcare professionals and regulatory agencies make informed decisions while ensuring patient safety.

How it Benefits

The Causality Matrix simplifies the assessment process by:

Managing large volumes of cases efficiently.

Gathering all relevant information needed for analysis.

Evaluating key factors that determine the likelihood of causality.

Assigning a causality level to ensure accurate classification.

By comparing pre- and post-implementation, organizations can see improvements in case processing, streamlined evaluations, and accurate submissions that align with regulatory requirements.

How We Are Using This in Existing Products

In PvEdge^®, the Causality Matrix automates and structures the assessment of drug-event relationships. It provides a guided approach to collecting case-specific data, evaluating necessary parameters, and assigning a causality level based on predefined criteria. This ensures consistency, reduces manual errors, and speeds up the decision-making process in pharmacovigilance workflows.

Result of Implementation of PADER

Time Savings

Faster assessment of drug-event relationships, reducing manual workload.

Higher Productivity

Streamlined workflows allow teams to handle cases more efficiently.

Better Accuracy

A structured approach minimizes human errors in causality evaluation.

Scalability

The system adapts to increasing case volumes, ensuring seamless operations.