While demand for skilled clinical research professionals is at an all-time high, identifying candidates with the required skill sets is challenging.
This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.
All clinical researcher professionals receive extensive training on Good Clinical Practice and other processes to be followed in their work. A topic that is only superficially covered is why those processes are required.
Assessing the capacity of a clinical research coordinator (CRC) is one of many challenges involved in managing clinical trials—which are heterogeneous and increasingly complex, with rising regulatory burdens and tight budgets.
New European Union legislation that requires clinical trial master file data to be kept for 25 years from study completion requires actions from sites – including those based in the United States.