THOUGHT LEADERSHIP

The globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. Before the ability to efficiently conduct a global clinical trial, separate region-specific trials were required in a number of major markets. Recent advances in technology, and collaborations among regulatory agencies, have shortened the time to gathering the data necessary for multi-region approvals. But globalization comes with a number of challenges that may be daunting for small and emerging biopharma companies. For these sponsors, there are advantages to partnering with a small global CRO. Here, we will look at PROMETRIKA’s solution to meeting the diverse regulatory requirements presented by global trials.