Month: July 2018

In our mid-2018 compliance review, we look at inspection challenges faced by companies across the world. In the first half of this year, manufacturing compliance challenges dominated headlines. But we also saw shortcomings at major pharmaceutical companies like Pfizer, Bayer…

Paying sites on time is critical to a trial’s success, sponsors agree, and most believe they’re making the grade. So why are sites so frustrated with how they’re paid? Are their expectations unreasonable or are sponsors operating in the dark?…

The industry has been abuzz about risk-based monitoring (RBM) for much of the last decade, with the FDA indicating that it would like to see more sponsors give it a try. But in practice, many companies are only just beginning…

While the FDA is preparing to develop and implement a program evaluating the potential use of real-world evidence (RWE) for regulatory decision making, a panel discussion at this year’s DIA Global annual meeting described how the industry is already using…

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 was the thrust of the DIA session Assessing the Impact…