61 - Operational Excellence in Clinical Trials Monitoring & Data Management (S23E2)

In this episode, we revisit the critical operational components that make up clinical research. This discussion will offer effective methods for monitoring the study process and the key quality assurance procedures that are necessary to support compliance.

We have prepared some practical advice that will give insight into optimizing your processes and will include how to successfully manage risk and prepare for audits. The overall goal is to make these clinical processes as efficient as possible while keeping everything complaint with current good clinical practices.

This information will be delivered by utilizing the heavy hitters of research, for example, Title 21 of the CFR (Code of Federal Regulations). In addition to this, we will also be looking at GMP (Good Manufacturing Practice) and FDA training to deliver this content.

This allows us to emphasize how important it is to have consistent quality in all areas of a clinical trial. We need qualified people running the show and for the research to be completed in a suitable facility.