Amy is a leader with experience in clinical trial program operations and regulatory compliance. As a results-driven professional, she has a proven ability to oversee program processes, project management, quality improvement, and timely execution of clinical trials. Knowledgeable in academic and large healthcare settings, as well as public health and private physician practices. Her areas of expertise focus on early phase human pharmaceutical clinical research in the specialties of pediatrics, oncology, neurology, cardiology, infectious disease, dermatology, and diabetes. This week we discuss the increasing complexity of clinical trials operations, connecting SOPs to processes and the difference between QC and QA.