A Source of Invaluable Product Safety Data

Whether your product is pre-market or post-market, your adverse event data and data analysis supports good product stewardship and is extremely valuable. This data can help confirm a predicted risk profile as well as yield important information regarding unintended and unexpected effects or use patterns. However, informed and expert analysis of this data is needed for accurate interpretation. This eliminates the risk of data being misinterpreted or taken out of context.

28 Years of Experience in Context-Oriented Data Analysis

SafetyCall® professionals are experts at analyzing spontaneously reported incident data to develop meaningful, relevant information that produces actionable knowledge. SafetyCall experts understand the strengths and limitations of spontaneously reported adverse events. Using our experience and analysis skills we will help you see the big picture that is often hidden in the myriad of details.

Important Benefits of Expert Analysis

“The data does not speak for itself.” Expert, context oriented analysis is critical. This analysis finds meaning in mountains of data. Among the chief benefits, adverse event data analysis by experts can help manufacturers:

• Confirm pre-market assessment predictions.
• Define a relative Product Safety Profile.
• Identify intended and unintended usage patterns that may contribute to unintended effects.
• Assess performance of the product when used by itself or in the presence of other products or substances.
• Ensure that effects in “unique” populations are considered when evaluating risk.
• Fill in missing details regarding the overall product experience to see the big picture.
• Sort out the “background noise.”
• Support regulatory re-registration or initial registration of similar formulations or ingredients.