Proactive Signal Detection and Management
At Soterius, we take a proactive approach to signal detection and management, ensuring the early identification of potential safety concerns. Our experienced pharmacovigilance team conducts targeted literature surveillance and comprehensive adverse event reviews, assessing both serious and non-serious cases. By actively participating in signaling and trend analysis meetings, we collaborate with stakeholders to validate signals and provide actionable safety recommendations, helping sponsors maintain regulatory compliance and protect patient well-being.
Global Regulatory Expertise and Multi-Therapeutic Coverage
Our experts bring deep knowledge of global pharmacovigilance regulations, including EU-GVP, USFDA, and ICH guidelines, ensuring that all safety monitoring activities align with international standards. We specialize in safety signal detection across diverse therapeutic areas, including oncology, anti-parasitic drugs, and ROCK2 inhibitors, particularly during early drug development. By leveraging our expertise across multiple disease areas, we help sponsors anticipate risks and enhance the safety profile of their products.
