Pharmacovigilance is vital when conducting clinical trials. Our approach includes:
- Serious Adverse Event (SAE) reporting and follow-up
- Safety system/database design
- Online coding (MedDRA, WHO-ART) of adverse event information
- Preparation and submission of global safety reports
- Preparation of IND safety reports and alert letters
- Medical monitoring
Rigorous safety investigation has helped many new drugs enter the marketplace. We provide:
- Safety data management, processing, and reporting
- Data Safety Monitoring Board establishment and management
- Regulatory affairs expertise