Safety Adverse Event (SAE) Management During Clinical Trial Conduct

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  • Triage of all initial and follow-up source documentation to ensure criteria for a reportable case(s) are met and review for accuracy and completeness
  • Assignment of case numbers to all new SAEs
  • Obtaining the causality assessment from the medical monitor within 24 hours
  • Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports and diagnostics reports, etc)
  • Drafting of safety narrative(s) according to ICH guidance encompassing relevant information and query the site for additional information
  • Completion of MedWatch/CIOMS forms
  • Provision of Global Submission of SUSARs to regulatory agencies

 

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.  

> LEARN MORE ABOUT PHARMACOVIGILANCE AND SAFETY MONITORING 

 

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