Large-scale, multi-country real-world evidence (RWE) studies—including in Central Nervous System (CNS) indications—have the potential to deliver critical new insights. Many sponsors, however, remain ...
We knew it was coming, and now it’s close. By the end of 2024, the US Food and Drug Administration (FDA) is expected to formally make reviews by a single institutional review board (sIRB) the standard ...
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