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Safety Surveillance
Comprehensive Safety Surveillance services to ensure the ongoing safety and efficacy of pharmaceutical products. Artixio’s services involve the continuous monitoring and evaluation of adverse events and other safety data collected from various sources. The process includes signal detection, risk assessment, and trend analysis to identify potential safety concerns. Additionally, Artixio provides detailed safety reports and ensure compliance with global regulatory requirements.
Medical Writing
PADER/PSUR/PBRER/DSUR
Authoring
Review
Publishing
Submission
Aggregate report scheduling
Adhoc reports
Signal Management
Signal Detection
Quantitative Analysis
Qualitative Analysis
Signal Validation
Potential Signal
Valid Signal
Refuted Signal
Signal Prioritization
Risk Management
Health Hazard Assessment
New RMP authoring
RMP Updates
RMP maintenance
Risk Evaluation & mitigation strategy
Blogs
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