Managing Financial Risk at the Site Level: Practical Strategies for Underfunded Studies

Blog

Many organizations face financial strain as they are asked to support investigator-initiated clinical trials with little or no budget or to absorb hidden costs arising in sponsor studies. Practical strategies are needed to identify and manage this risk at sites, using tools to evaluate feasibility, recover costs and make decisions at the portfolio level. This will enable continued innovation, while building mission-driven research efforts that are likely to gain funding in future.

The Need for Clinical Research Sites to Transition to e-Regulatory Binders: Strategies, Pros, and Cons

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.

Measuring Quality in the Age of AI: Why Regulatory Writing Needs a True Standard

Clinical Researcher

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.

Enhancing the Quality of Investigator-Initiated Trials Through Self-Study Modules

Clinical Researcher

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.

From Mapping Your Pathway to Traversing a Career

Clinical Researcher

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.”