The amount of time and money it takes for a drug or medical device to be developed and pushed to market is staggering and continues to grow. However, more often than not, once a product gets approved, the maker enjoys watching it flourish in the global marketplace for many years.
Unfortunately, there are situations when drugs and devices are withdrawn from the market. Products are typically taken off the market due to unexpected serious adverse events (SAEs) that were not detected during a phase III clinical trial and only became apparent from post-market surveillance data that was gathered from the wider patient community.
Visual Presentation of Safety Signals in Empirica Signal
Although a withdrawn product could potentially damage a company’s image and burn a large hole in its pockets, more importantly, lives are at stake. It is essential for life sciences companies to take every means possible to ensure their products are safe for public use.
Due to the implications associated with a withdrawn product, as well as new pharmacovigilance regulations, there is a tremendous focus on signal management the process of detecting, prioritizing, and evaluating determined signals in a data population. Employing a signal management process, such as the one proposed by Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII, companies can be alerted to potential safety issues early on, preventing SAEs and ultimately saving lives.
One of the most effective ways to perform signal management activities is through the use of signal detection software, such as Oracle’s Empirica Signal and Empirica Topics. Applications like these are designed to help companies scour adverse event report data to uncover, investigate, and document potential drug safety signals. In fact, even the U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and other government organizations use the Empirica software suite.
To learn more about signal detection, click here to read a recent interview with Dr. Rodney Lemery, Perficient’s director of safety and pharmacovigilance.
