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Other Safety Expert Services
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Home
Clients
Clinical Trials Sponsors
CRO Partners
Post-marketing Clients
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
Post-marketing Clients
Post-marketing Expert Consultation
1. Expert Consultation
Post-marketing PV functions, and department, and team building
PV medical safety assessment trainings, PV SOPs/ WIs/ templates development
PV database and PV system updates
Published literature review strategy
Safety signal detection and data mining (e.g., MGPS) and risk management update
Development and updates CCDS safety and local labels
.
PV audit and inspection
Assessment and management of product quality issues and product recalls/withdrawal.
Safety regulatory reporting and submission
Safety data exchange agreement (SDEA) development
Establish and manage safety related off-shore and outsourcing models and activities.
Safety database data listings and reports development
Signal detection data integration (e.g. : EDC and safety database) and review support
2. Project Services
Post-marketing AE/SAE case processing
Published literature and
pharmacoepidemiology
review
Aggregate safety report development
Periodic safety update reports (e.g., PSUR, PADER, PBRER, ASR, Summary Bridging Report, Addendum)
Ad Hoc Safety Reports (e.g., Clinical overview/summary for labeling update, Safety expert report for assessment of safety queries)
Other reports (e.g., Medical impact analysis (MIA) reports, Safety summary, Customized line listings and summary tabulations for aggregate data)
Safety signal detection and data mining (e.g., MGPS)
reports
Ongoing evidence-based risk/benefit assessment and RMP update
Real world studies and experience safety data review support
1. Real world studies
Safety data collection strategy
Data cleaning standardization, and quality control
Data processing and application design
2. Real world experience
Provide professional supports for:
Medication OTCs, nutrients, food supplements, medical devices
Patent population and risks assessment
Safety data monitoring and risk mitigation
Product complaint medication errors monitoring and management
1. Product complaint
Safety review plan
Medical assessment of potential impact
Post-marketing safety data retrieval and summary
2. Medication errors monitoring
AE data review and database search strategy
Issue driven data summary and presentation
Regular team review and risk medication
Summary and impact assessment for periodic safety update report
Online remote
PV monitoring and chronic disease risks management
1. Common drug safety risks monitoring
Drug-drug interaction
Drug-food interaction
Drug-disease interaction
Drug-use noncompliance
Overdose
Drug abuse
2. Other safety risks
