Clinical Researcher

Institutional review boards (IRBs) are federally required committees that evaluate research involving human subjects to safeguard participants’ rights, safety, and well-being. Their oversight guarantees adherence to federal laws, institutional policies, and ethical standards. Before starting any study with human participants, researchers must submit their research plans to the IRB for review and approval.

As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research associates (CRAs) from traditional compliance monitoring to proactive, data-enabled site support and oversight. Skill development, structural changes, and the use of advanced analytics are modernizing the CRA role—and the way we monitor clinical trial sites.

Global trials can unlock real advantages for sponsors, including access to diverse patients, faster enrollment, and more representative data across geographies. However, global expansion isn’t always the right move. For every sponsor that benefits, there’s one that overspends, underdelivers, or enters markets they were never built to support. In a high-risk industry that punishes missteps and rewards efficiency, the question any sponsor should ask isn’t how to go global. It’s whether they should at all.

Healthcare has always been slow to adapt to change. When other industries appear to be on time or at least close to catching up to the latest trend in the market, rest assured, healthcare is about a decade behind. However, one area where healthcare cannot afford to lag behind the times is the use of digital health—specifically, artificial intelligence (AI).

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.