signal management

Signal Management Services

ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

ProPharma's simple but scalable model of signal detection and management allows clients to obtain the exact services necessary throughout the entire life cycle of their products.

Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products that require the utmost expertise. Signal management can be deployed throughout both the clinical development and post-marketing phases of the product lifecycle. Safety issues may affect the benefit-risk balance of the product, requiring updates to product labels and other steps that help protect patients from harm.

Signal Detection in Pharmacovigilance

Signal detection in pharmacovigilance is the systematic process of identifying and evaluating potential safety signals in the data relating to a pharmaceutical product. This process involves scrutinizing various data sources for previously unrecognized adverse events or changes in patterns of known adverse events, which might be caused by a medicine. This is vital to monitor and assure the safety of a pharmaceutical product throughout its life cycle.