What we offer
Fully managed services, that leverage evidence-based statistical results and experience-based physician monitoring, to decipher drug clinical behavior, detect safety signals, evaluate and categorize potential risks, and identify needs for data collection
Who is it for
Heads of drug safety and pharmacovigilance teams
Why it’s important
Identify new potential risks from across sources
Monitor changes in identified risks continuously
Ensure patient safety at all times
How we deliver
We bring with us extensive data-mining expertise across FDA AERS, clinical trials, other data sets, time series analysis, along with automated analysis capabilities for aggregate data review of heightened surveillance products with open signals.
We identify signals by monitoring various sources that include safety and regulatory databases, LPs, company studies, published and unpublished medical literature, preclinical studies, product complaint information, and more. The robust signaling and surveillance framework allows monitoring teams to customize workflows and signal thresholds for different products.
This, along with evidence-based statistics from past signals, ensures effective detection mechanisms.