Work from early pharmacologic data to get to IND and beyond: Identify nonclinical development needs Pharmacology studies Bioanalytical assays Investigational drug product Nonclinical toxicology studies Safety pharmacology studies Identify stages which need to be conducted by GLP Timeline to IND filing Prepare Investigational New Drug (IND) submission Facilitate interactions with FDA to resolve regulatory issues Write clinical Standard Operating Procedures (SOPs) Design and implement first-in-man Phase I safety study Write clinical study protocol Construct Case Report Forms Place study and negotiate contracts Provide medical monitoring Provide project management Review all data listings for accuracy Design formats for Tables, Listings and Figures for report Write clinical study report according to FDA/ICH guidelines