This book is designed to serve as a guide for sponsors and CROs to conduct clinical research studies efficiently and successfully.

This book will cover an insight on all the major activities of a sponsor like Project Milestone Planning and Forecasting, Trial Design, Financial Planning, Grant Allocation, Site Selection, Contracts and Agreement, Vendor Selection and Management, Preparation of Trial Binders, Management of Regulatory Document Submission, Investigator Training Meeting, Import Export Requirements for Clinical Trials, Study Initiation, Conduct and Milestones Tracking, Audit(s) and Quality Assurance, Regulatory Inspection, Safety Reporting, and Compliance, Study Payments, Regulatory Inspection, Site Close-out, Study Close-out, Final Study Report, Archival, etc.