By Craig Morgan NZCS, MBA (Hons), PMP, goBalto, Inc.
Standard Operating Procedures (SOP) rarely grab the spotlight like transformational technologies or newer strategies, such as risk-based monitoring or Quality by Design. But, SOPs deserve some love. With their coveted goal of improving operational efficiency, they have long been fundamental to many industries, and the clinical trials sector is no exception. Sponsors are motivated to develop SOPs, not only as a standard business practice, but also in support of regulatory compliance. For example, Good Clinical Practice (GCP) guidelines state that audits generally involve a systematic review of trial related activities and documents, including SOPs. Yet, just because a company has invested significant time and resources in creating SOPs does not mean they are always being followed. They may even be avoided.