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
Risk Management
Our safety team shines in dealing with risk management of drug safety and pharmacovigilance.
Risk Specifications
Summarizing of nonclinical and clinical safety
Presentation of important identified or potential risks
Review of relevant epidemiology data for important risks
Finding important missing information or other safety concerns
Strategy for PV Plan and Risk Minimization Plan
Routine PV activities
Additional studies for risk evaluation
Routine risk minimization activities
Additional risk minimization activities
Following a proactive and integrative risk management strategy culminating in a credible Risk Management plan
Pre-approval risk assessment
Disease epidemiology review (e.g., nature history, prevalence, characteristics and patterns of disease severity and impact)
Proactive risk monitoring and signal detection in clinical trials
Integrated review of safety data from clinical pharmacology studies, randomized trials, and large simple safety study
Ongoing evidence-based risk/benefit assessment
Safety related amendment or updates (e.g., IB, ICF, SAP, DMP, SMP, MMP)
Post-marketing PV & Risk Management
Development of EU-RMP and risk monitoring approaches (e.g., Annex 1 for EU Vigilance Databases)
Designing US REMS, RiskMAP
Customized approaches for risk-specific assessment and risk minimization
RMP related PV activities: PSUR, PBRER, CCDS/product labeling update, safety studies, overall assessment of benefit/risk balance
