Clinical Study

• Literature search, Investigator’s Brochure, Protocols & ICDs
• Database Lock Narratives
• Clinical Study Report with appendices
• eCTD Modules
• Summary Documents

Drug Safety and Risk Management

• PSUR, Annual Report
• Safety & Medical Monitoring
• Safety Narratives
• Risk Management Plan (RMP)
• Pharmacovigilance Awareness Training
• Reconciliation of Serious Adverse Event
• PV Consultancy and Project Management
• Serious Adverse Event Case Processing of Initial/Follow-up/Closure reports