About Proactive Safety

As we move towards an increasingly information driven world, the incorporation of data science with business critical processes becomes essential. Key drivers of drug safety and pharmacovigilance have been compliance, automation, and digitalization. Here at Synapmed, we believe that “proactivity” is to be the next evolution of safety; specifically the incorporation of Real World Data and Real World Evidence into overall drug safety strategy. The 21st Century Cures Act, passed in 2016, emphasizes the usage of non traditional patient data from sources such as EHR’s, claims activities, and medical devices, to monitor post-market safety and adverse events and enable regulatory decisions. RWD/RWE plays a particularly important role in signal detection, providing additional data for potential signals that may be significant. This can be an especially useful tool for safety executives to help drive R&D and commercial strategy, as it provides the stimulus to shape overall regulatory operations. By incorporating RWD & RWE into safety strategy, Proactive Safety embodies a “patient first” mentality.