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Independent investigators play a vital role in advancing translational "bench to bedside" research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institution’s high-quality research and compliance.  

Historically, the vital task of assigning study coordinators to clinical trials has relied on a research leader’s experience and intuition. The realities of today’s challenging studies—with increasing complexity and tightening budgets—demand an accurate assessment of the level of support required for each trial. This is an essential step in maintaining quality while avoiding staff burnout.  

The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. This milestone is an opportunity for our field to grow and adapt in meaningful ways. ICH E6(R3) isn’t just an update—it’s a call to action.

In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the “nice to have” category into the “must-have” one doesn’t have to be dismissed as a miracle that will never see the light of day, an industry observer of trends in technology says. 

The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.