Clinical Safety
Products & Services
Information
Being a full-fledged CRO, developmental safety is a natural progressive line for us.
Our service line for developmental safety includes following:
1. CT Initiation support
• SMP
• MMP
• SUSAR tracking processing and submission
• 24*7 Clinical Site Inquiry Support
• 24*7 medical Monitoring Support
• AOSE Preparation
• Investigator Cover letter preparation and notification to trial sponsor
2. EU CT portal management:
• RPEV
• CTIS Portal management
3. CT medical safety
o Periodic Safety Listing Review
o SAR/SUSAR Line Listing Report
o Risk Management Strategies
o Development Safety Update Report (DSUR)
