Signal Management
Ensuring product safety for regulatory authorities involves gathering signals from a variety of sources. While data from clinical trials may be limited in scope once a product is authorized, sponsors are responsible for continuously monitoring and collecting information from spontaneous reports, clinical studies, and scientific literature to ensure ongoing safety.
Signal management process includes the following activities:
The processes adopted by the SentinelRX Signal Management team involves in-depth review and medical assessment of safety data. This is undertaken by a dedicated team of healthcare professionals, including physicians, under close supervision and oversight of experts.
We follow robust signal management processes to meet global and local regulatory requirements. We support sponsors in wide-ranging activities covering signal detection from multiple sources, signal validation, and signal analysis and prioritization.