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.

1. Clinical HOV Lane Standards Dr. Rao Teki Principal, Healthcare Solutions, HCL

3. Clinical HOV Lane Standards Clinical Trial Costs

4. Clinical HOV Lane Standards Pre Study Activities Study Conduct and Close out Submission Destination Starting point FDA Guidelines>Developed the standards We do not have the standards Monitoring Time LPLV FPFV Time

6. Subject recruitmentMonitoring Time LPLV FPFV Time

7. Physician Office Regulatory Guidelines Industry related updates GCP Training and Certification. Prepare the Site for Global Study. Pistoia Certified Site Continuing Clinical Research Education Program (CCREP) Periodic Training Access to Pistoia Certified Sites and Investigators SPONSORS and CROs GCP Training and Certification. Prepare the PI for Global Study. Pistoia Certified PI Pistoia Global standards for Investigators & Sites Hospital Regulators Pistoia Global Standards for Sitesand Investigators United Clinical World

8. Pistoia Certified Sites and Investigators Advantages: Pistoia Global Standards Certified Sites and Investigators Faster Study Initiation and reduced trial time and cost ($$) Distribution Globally - country or regional level sites Selection of best sites (w/ adequate infrastructure) & investigators, Based on their specific patient populations, Past clinical trial experience, currently available Personnel, and affiliations to other physicians and hospitals Improved subject enrollment and monitoring Unified view of investigator and HCP data Improved knowledge of investigator/HCP status and changes – qualifications Efficient process to handle increasing FDA audits and inspections of trials sites Improved report monitoring quality for study managers

9. Questions

10. Clinical HOV Lane Standards Thank you