Sites can add depth to their research teams by creating specialized positions and potentially free up existing staff to take on more trials. The challenge is in site managers or directors convincing site leadership — typically vice presidents — that the gains outweigh the costs. Read More
The FDA’s Good Clinical Practice Program (GCPP) fields dozens of questions each year related to completing and signing the Form FDA 1572 — Statement of Investigator. The following are some of the questions GCPP has received recently with answers from the program’s senior analysts. Read More
Human radiolabeled mass balance studies are the most direct way of gathering quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft guidance the FDA issued in early May. Read More
In an effort to increase the diversity of physicians engaging in clinical research, Abbott and Women as One, a nonprofit, have launched a program to train female and underrepresented physicians to conduct clinical trials. Read More
