Missing safety signals is the greatest concern for everyone in clinical development, especially medical monitors who are directly responsible for the well-being of trial subjects. With patient safety as the primary directive and concern for the entire clinical team, processes and technologies that can mitigate safety issues during medical review, in stream, all the time, are the gold standard.
Our Risk-Based Monitoring Solution is the most effective way to leverage data-driven insights to optimize site performance while improving patient safety. With the changing regulatory landscape, you must assess risk holistically, looking beyond just KRIs, by having the technology in place to ensure full data visibility and capabilities to identify and act on root cause for known risks.
Built on the best-in-class scientific analytics and data discovery platform, TIBCO Spotfire®, our innovative solution for pharmacovigilance, enables teams to strategically transform their medical review, safety review, and compliance monitoring processes; gain new insights leading to faster identification of safety risks early in development, and reduce the time and costs of preparing for safety team reviews.