Site personnel must be empowered to leverage critical thinking when developing and implementing adverse event (AE) reporting procedures in medical device studies, two leading experts say. It might sound like […]
Although advocates for lupus research have counted flawed clinical trial designs and a lack of biomarkers to predict drug response in trials as among the historical barriers to developing better […]
Adequately trained monitors/clinical research associates (CRAs) “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, […]
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 […]