Regulatory Compliance: An Increasing Burden On Sites

Assessments conducted by CenterWatch and other organizations (e.g., the Institute of Medicine) during the past two decades consistently have found that regulatory compliance represents one of the most demanding and difficult tasks for investigative sites. Indeed, articles published in peer review literature throughout this period—including those with telling titles such as Slow Death by a Thousand Unnecessary Policies—point to high awareness and consensus of this critical problem among stakeholders throughout the clinical research enterprise. Yet, until now little to no quantitative data has been available measuring the magnitude of the regulatory compliance burden on investigative site operations with an eye toward identifying improvement opportunities.

At the present time, sponsor companies and contract research organizations are actively pursuing new approaches to improving investigative site relationship effectiveness and study conduct efficiency. Regulatory agencies also have increased interest in easing the burden for investigative sites to comply with Good Clinical Practice and International Conference on Harmonization requirements. As such, the timing of this new CenterWatch-Complion study couldn’t be better. It not only provides hard evidence of regulatory burden, but also characterizes current levels of investigative site infrastructure and systems to manage that burden.