Safety Adverse Event (SAE) Management During Clinical Trial Conduct
Pharmacovigilance and Safety Surveillance
Pre-Approval and Post-Marketing Pharmacovigilance and Safety Monitoring
While it is critical to ensure patient safety throughout clinical trial planning, execution, and the regulatory approval process, it doesn’t end there. Once a therapeutic receives regulatory approval, long-term safety monitoring begins to ensure continued patient safety.
We can help you develop, negotiate, and implement your Risk Management Plans with the regulatory agencies. The process begins during the preparation of the marketing application (e.g., NDA, NDS, BLA, etc.) and continues post-approval for the entire time the product/therapeutic is on the market.