Prioritizing a Positive Patient Experience

Continued progress in modernizing clinical trials is essential. This should include evaluating appropriate use of technology and the potential of non-traditional sites, such as retail pharmacies, as well as offering at-home services to study participants.
Romie Mushtaq, MD, Chief Wellness Officer, Great Wolf Resorts

Getting to the Root of the ‘Busy Brain’ Challenge Can Lead to Better Research Conduct

If “being more mindful” isn’t already among your New Year’s resolutions for 2024, an expert on the negative consequences of having a “busy brain” thinks it should be, and that intellectual, stress-driven professionals like those who are often drawn to clinical research will benefit from pausing to process their thoughts and emotions more methodically. 
Photograph of Liz Beatty

Success in Selectivity: Giving Sites the Power to Pick the Right Trials

Today, large academic research centers receive the vast majority of trial opportunities, leaving countless other sites constrained by studies that don't align with their strengths. It’s not uncommon for experienced and motivated sites to accept the majority of opportunities that come their way, even when it's not the best match for their team and patients. This results in highly qualified sites underperforming across trials – not because they lack the ability to deliver results, but because they lack the power to be strategic and selective in choosing trials.

Understanding a Site’s Responsibilities for Essential Documents in Electronic Systems

Many site personnel, upon assuming responsibility for a new eRegulatory system, may not immediately recognize that, in addition to managing access credentials, the U.S. Food and Drug Administration now requires compliance with the guidelines outlined in the owner’s manual, specifically addressing electronic records and signatures as per 21 CFR Part 11 in the Code of Federal Regulations.