PHARMACOVIGILANCE
Pharmacovigilance is vital when conducting clinical trials. Our approach to pharmacovigilance includes:
- 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 a new drug into the marketplace. We provide:
- Safety data management, processing, and reporting
- DSMB establishment and management
- Regulatory affairs expertise