Adverse Event Management

ADVERSE EVENT DATA ANALYSIS

A Source of Invaluable Data

Most likely, your market population is much larger than any of your pre-market test populations. This means the adverse event data collected from your market population is extremely valuable. This data can help confirm a predicted risk profile as well as yield important information that may not have surfaced during pre-market testing. Without informed and expert analysis this data can be misinterpreted or taken out of context.

28 Years of Experience in Context-Oriented Data Analysis

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

Some 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.