Clinical Researcher

Clinical research trials have long relied on paper regulatory binders to manage essential documents required by regulatory authorities, sponsors, and research teams. However, with the increasing complexity of clinical trials, the shift toward electronic regulatory (e-regulatory) binders has become essential to improve efficiency, compliance, and data management.

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.