Drug safety is critical to protect patients and consumers exposed to pharmaceutical development and commercialized drugs. Although the principal framework for Drug Safety and PV operation is similar for all small pharma, biotech, and medical device companies, organized collection and analysis of this segment’s PV profile and process is limited. Efficient and effective drug safety management is essential for overall regulatory compliance and patient safety.
In 2023, we initiated the PV Insight Network, a collaborative effort aimed at this significant yet largely underserved healthcare segment. This segment has been a pivotal force driving innovation in medical care, including accelerated clinical trials, medical devices, gene therapy, and rare diseases. We actively sought the participation of our Network, comprising over 100 drug safety leaders from small pharma, biotech, and medical devices, to provide real-world input on the current state of their product portfolio, processes, and the use of technology. We delved into the key challenges within this group, subsequently identifying consistent themes across the cohort.