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

Process

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signals by monitoring various sources that include safety and regulatory databases, LPs, company studies, published and unpublished medical literature, preclinical studies, product complaint information, and more.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. 

What makes us different

Automated signal detection by integrating statistical and non-statistical methods

Data-driven and rule-based auto-signal validation and prioritization

Proactive identification of appropriate data sources

700
Signal surveillance and evaluations
5
Signal Detection Tool Expertise
10
Therapeutic areas