This document discusses clinical HOV lane standards, including: - Pre-study activities, study conduct and close out, and submission standards aimed to develop a united clinical world. - Standards include global standards for investigators and sites, subject recruitment, monitoring timelines such as LPLV and FPFV. - The Pistoia certification program aims to certify sites and investigators to facilitate faster study initiation and reduce costs through a global network of qualified sites and investigators. - Benefits of Pistoia certification include improved subject enrollment, monitoring, and knowledge of investigator qualifications and changes over time. It also enables more efficient FDA audits and inspections.