What to Know
Data collection, analysis, and monitoring are the drivers of the pharmacovigilance field. Safety signal detection narrows the focus to working with adverse event data.
Signal detection culls trends or patterns from across a range of data types. Safety signals can emerge from clinical trial and meta-analysis reports to animal testing results or spontaneously reported findings. Signal detection activities serve to answer these overriding questions:
- Is this a new risk relating to this drug?
- Have risks associated with this drug changed based on what the data shows?
How We Can Help
Our experienced experts are sought after for their ability to lead or support all phases of safety signal detection. We can consult with your team at any point in the process, to:
- Conduct clinical and marketed signal detection and analysis (all or part)
- Perform continuous monitoring of your product’s safety data looking for safety signals
- Assist with signal validation, prioritization, and assessment
- Define and implement the appropriate steps