Home
Clients
Biopharma Companies
CRO
Organization
Services
ICSR
Aggregate Safety Reports
Risk Management
Safety Signal Detection
Clinical Trials Safety Services
Pharmacovigilance (PV) Training
Other Safety Expert Services
About Us
Contact Us
Menu
Home
Clients
Biopharma Companies
CRO
Organization
Services
ICSR
Aggregate Safety Reports
Risk Management
Safety Signal Detection
Clinical Trials Safety Services
Pharmacovigilance (PV) Training
Other Safety Expert Services
About Us
Contact Us
Safety Signal Detection
Another strength of our safety team is the ability to provide the high-quality service of safety signal detection for our clients.
Signal assessment strategy
Medical concept and risk assessment
AE terms grouping
Development of targeted questionnaires for AEoSIs
Signal monitoring
Real-time risk monitoring for potential safety signals
Targeted follow-up for identified Adverse Event of Special Interests (AEoSI)
Weekly, monthly or quarterly reviews of safety data/line-listings
Integrate review of clinical trials data across protocols or programs
Signal analysis
Confounding and risk factor review
Review background rates in overall populations (or disease-specific populations)
Review drug exposure and estimated reporting rates
Understanding safety signals and taking appropriate precautionary measures
Additional risk data search and review
External database (e.g., FAERS) review
Data-mining for assessment of potential safety issues
Review of competitors’ labeling documents
Targeted literature review and summary
