Comprehensive Medical Review of Serious Adverse Events (SAEs)
At Soterius, our team of experienced physicians conducts meticulous medical reviews of Serious Adverse Events (SAEs) to ensure accuracy, completeness, and compliance with global regulatory standards. By evaluating critical factors such as seriousness, causality, and expectedness, we deliver reliable, high-quality safety data that empowers informed decision-making and ensures seamless regulatory submissions.
Our physician reviewers specialize in identifying missing or ambiguous details during the SAE triage process, promptly generating structured site queries to resolve discrepancies. This hands-on, physician-led approach ensures clarity, reduces ambiguity, and maintains consistency in SAE reporting. By streamlining case reviews and minimizing delays, we align safety data with the highest global standards for clinical trials and post-marketing surveillance.
