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The safety of clinical trial participants is paramount. Our Bio-Pharmaceutical Development Safety Team annually receives and processes on average 4,000 serious adverse reports. We quickly and accurately research and report SAEs to the FDA and/or other regulatory agencies. With knowledgeable medical and clinical professionals on staff, TRI capably provides the following safety and pharmacovigilance services:
- Expedited Adverse Event Reporting
- Interpretation of Federal and International Safety Regulations & Human Subject Protection Regulations / Guidelines
- Informed Consent Development/Translation
- Safety Review of Clinical Protocols & Informed Consent Documents
- Development of Toxicity Profiles for Investigational Agents
- Report Preparation, including:
- IND Safety Reports
- Investigator Safety Reports
- Final Clinical Study Reports
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