TRI appreciates the importance of attention to detail, scientific accuracy, and adherence to format in the writing and assembly of regulatory documents. We have developed and implemented stringent quality control measures to ensure accurate and efficient writing and preparation. With over three decades of experience in establishing, operating, and maintaining customized databases and enterprise systems for the receipt, assessment, and reporting of Serious Adverse Events (SAEs) and Unexpected Adverse Device Effects (UADEs) TRI receives and processes more than eleven thousand SAEs per year. We have the flexibility to use your electronic reporting systems or our in-house technology for SAE and AE case management and reporting.
Key Services
- Regulatory Reporting
- AE/SAE evaluation, narratives, physician review
- Generation of MedWatch 3500A/CIOMS I Forms
- Timely regulatory submissions
- Aggregate reporting per FDA Final Rule requirements
- Safety Monitoring Committee/DSMB Management
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs) and Annual Reports
- Dictionary Management
- MedDRA coding, upversioning, uncodable AE terms review, and MSSO submissions
- CTCAE coding
- SOPs and report templates
