Blog

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. 

Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, HCA Healthcare Research Institute has a centralized approach to reducing start-up timelines. HCA Healthcare Research Institute is a site management organization with around 40 sites and 275 open trials.

Clinical study start-up is a complex process, involving many moving parts, which can sometimes feel overwhelming. Using strong project management skills to follow a clear road-map, with well-defined workflows, can make the difference between costly delays and success. These skills can enable timely study initiation by enabling sites to handle complexities and minimize delays. 

Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union or UK residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Securing, anonymizing, and transferring personal data is complex and challenging in these regions, especially when there is a need to share personal data with vendors and research partners in multiple jurisdictions.