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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
Expert Consultation
For Sponsor
Expert Consulting Services
Contract Team Services
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IND / NDA preparation and submission
Pre-IND regulatory(e.g. FDA) commucation
Original IND package preparation and submission
First in human ("FIH") study and medical safety monitoring
Key opinion leaders (KOLs) interactions and study design recommedations
NDA preparation and submission supports:
Integration safety summary (ISS) or summary of clinical safety (SCA)
Safety issues or concerns data preparation strategy and solution
Overall safety profile assessment and risk management planning
Labling development support
Post-marketing safety moniotoring planning
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
