Insights

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.

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.