A new guidance from the U.S. Food and Drug Administration (FDA) provides the agency’s latest thinking on how it defines the types of changes to approved risk evaluation and mitigation […]
Eva Mozes Kor, a survivor of Nazi experiments conducted on twins by Dr. Josef Mengele during World War II and a memorable two-time speaker on the importance of medical research […]
The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. That […]
Did you find yourself breathing a sigh of relief at some point in the past year, thinking all the hullabaloo over the theories and practices of risk-based monitoring (RBM) and […]
Gatherings of representatives from clinical trial sponsors and sites aren’t always inspiring or uplifting, but don’t tell that to Victoria DiBiaso, from Clinical Sciences & Operations in Sanofi’s R&D organization. […]