Insights

If there’s one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, it’s change. In Q4 of 2024 alone, new guidance documents were drafted or finalized on a number of topics.

People who are entering the clinical research profession can come from many other fields and with very diverse backgrounds. No matter their role, everyone acknowledges project management as an essential and invaluable skill set. Project management requires leadership, communication and management skills that can be applied in any role across clinical research.  

The ICH E6(R3) guideline for Good Clinical Practice (GCP) was adopted by regulatory members of the ICH Assembly on January 6, 2025. The final version of the updated guideline, which aims to foster a culture of quality as technologies and methods evolve, is now recommended for adoption by regulatory authorities in ICH regions, which include the U.S., Europe, and Japan.  

As many as 20% to 50% of clinical trials do not accrue participants at the site level, leading to wasted time and financial resources. This waste can be minimized by early selection of trials most likely to succeed. The protocol feasibility review process informs this selection by offering a way to evaluate logistical elements of a clinical trial before the activation process is started.