07 Aug Opinion: Quality vs. Compliance Mentality Pits the ‘Good’ Against the ‘Best’

By Larry Kennedy, ACRP

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success. However, despite their frequent association, these terms embody distinct philosophies and practices. 

Quality is a holistic concept referring to the degree of excellence of a product or service in all aspects that contribute to customer satisfaction, including performance, reliability, durability, and aesthetics. It focuses proactively on meeting or exceeding customer needs, wants, and expectations through diligent process management and continuous improvement and innovation. 

By prioritizing quality in clinical research, organizations aspire to enhance their competitive edge, reduce costs through efficient processes, and foster a culture of excellence. Everyone benefits, especially the participants in clinical trials and the ultimate recipients of the data they produce—patients undergoing treatment. Read more…