How to Be Your Own Internal Monitor When Inspectors or Auditors are Coming

Those in clinical research who most strongly believe the old saying about how “the best offense is a good defense” may often be the same people who have good reason to understand that a regulatory inspection, sponsor audit, or period of institutional review board (IRB) scrutiny could descend upon their study site at any time, announced or unannounced, so the best tactic is ongoing vigilance.

Unlocking the Power of Digital Biomarkers in Clinical Trials

Unlike traditional clinical outcome assessments, which rely on intermittent and sometimes subjective clinic-based measurements, digital biomarkers enable a richer, more dynamic understanding of disease progression and treatment response. This article provides examples of how digital biomarkers are revolutionizing clinical trials, focusing on the authors' shared experiences managing trials within the fields of neurology and oncology.

Stepping into Leadership—What is Needed for New Managers to Excel

Stepping into leadership can be daunting. Whether it is becoming a line manager, or leading a study for the first time, as careers progress, priorities shift and more emphasis is placed on interpersonal and organizational skills. This can lead to self-doubt for first-time managers. A quarter of managers say they did not feel ready to lead others when they were first appointed.

P3: People Powering Protocols

The clinical trial industry has a problem--one that is exacerbated by flawed protocol designs, unrealistic inclusion/exclusion criteria, and other factors. Put simply, the industry must finally design trials around real-world patients and stop extrapolating narrow clinical trial data to wider patient populations.