Ensuring patient safety and regulatory compliance is critical in clinical trials and post-marketing surveillance. At Soterius, we provide end-to-end Clinical Safety Case Processing and Expedited Reporting services, ensuring seamless adverse event case handling, data entry, medical assessment, and timely submissions to regulatory authorities. Our experienced pharmacovigilance team ensures that Individual Case Safety Reports (ICSRs) are processed accurately while adhering to global standards such as FDA, EMA, and ICH E2A guidelines.
Our expedited reporting services prioritize swift identification and submission of serious and unexpected adverse events, meeting strict global regulatory timelines. With all cases triaged by a physician and using advanced safety databases and automation tools, we enhance accuracy in MedDRA coding, narrative writing, and causality assessments. Soterius also conducts continuous signal detection and risk management to help clients proactively address safety concerns and mitigate potential risks in real-time.
