Insights

The use of generative artificial intelligence (AI) in regulatory medical writing is expanding rapidly, yet the industry still lacks a standardized way to define and measure “quality.” Without measurable baselines, organizations cannot demonstrate whether AI-assisted drafts meet regulatory expectations or improve over time.This article outlines an emerging, multi-layered framework for evaluating AI-generated content in regulatory submissions.

Investigator-initiated trials are essential for driving innovation and advancing clinical research. However, these studies often lack structured monitoring and quality oversight. While Good Clinical Practice trainings exist, many are too broad, costly, or inaccessible. To address this gap, the authors of this article developed the Clinical Trial Quality Training Series, three self-paced modules (Monitoring, Auditing, and Inspection Readiness) that are guided by an implementation science framework.

Building on earlier work, the authors of this article have taken a broader look at the clinical research profession to be more inclusive of the career opportunities found with pharmaceutical sponsors, contract research organizations, commercial institutional review boards, and technology solution vendors, redirecting their vision from the original “tube stop” concept to a new “Airport Concourse Model.”

The success of complex and advanced therapeutic clinical trials depends heavily on a capable and adequately trained investigative workforce. One key yet often underdeveloped component of this workforce is the research-naïve principal investigator (PI)—a clinician who possesses the medical expertise required to oversee a study but lacks substantial experience in clinical trial leadership as they enter their first such experience.

Turnover in clinical operations is often discussed as an unfortunate reality of a demanding industry. Long hours, aggressive timelines, and increasing complexity are cited as unavoidable contributors. But after more than two decades leading clinical teams across sponsor and contract research organization environments, the author of this column has come to see turnover differently.