Proactive Signal Detection and Risk Management in Drug Safety

Why Early Detection of Safety Signals is Critical

In pharmacovigilance, signal detection refers to the identification of new, previously unknown risks, or changes in the frequency or severity of known risks related to a drug. Detecting safety signals early in the drug lifecycle—whether during clinical trials or post-market surveillance—is essential to prevent patient harm and avoid regulatory non-compliance.

Viltis offers advanced signal detection services using sophisticated algorithms and real-time data monitoring to identify potential safety concerns. By leveraging automated tools, we can sift through vast amounts of data from various sources, including:

• Clinical trial data
• Post-market adverse event reports
• Scientific literature
• Real-world evidence (RWE)

How We Detect Safety Signals Early

1. Spontaneous Reporting System (SRS): Our signal detection begins with collecting spontaneous adverse event reports from healthcare professionals, patients, and regulatory bodies. This process allows us to identify patterns of adverse drug reactions (ADRs) that might indicate a safety signal.

2. Active Surveillance and Signal Detection Algorithms: We use statistical tools to detect unusual trends in large datasets. Whether it's a sudden increase in adverse events or a new type of ADR, we flag safety signals early to mitigate risks.

Risk Management for Ongoing Safety

Once a signal is detected, implementing a risk management strategy is crucial to safeguard patient safety and ensure compliance with global regulatory requirements. At Viltis, we develop Risk Management Plans (RMPs) that align with international guidelines from agencies like the FDA and EMA.

Our Risk Management Strategies include:

• Risk Identification: Detailed analysis of the identified signal to determine potential risks and their severity.
• Risk Mitigation: Proposing immediate actions such as dosage adjustments, warnings, or recalls, based on the level of risk.
• Risk Communication: Providing clear communication about risks to healthcare professionals, patients, and regulatory bodies.
• Continuous Monitoring: Ongoing assessment of the identified risk to determine its long-term impact and whether additional measures are needed.

By using proactive signal detection and robust risk management, Viltis ensures that safety issues are identified and addressed long before they become critical, thereby maintaining patient safety and protecting your product’s market status.