Services - Propose Clinical Trial Strategies - Develop Clinical Trial Protocols - Design Case Report Forms (CRF) - Design and Setup Database - Conduct Double Data Entry - Perform Data Management - Develop Statistical Analysis Plans (SAP) - Create CDISC SDTM/ADaM and Analysis Datasets - Develop SAS Programs - Conduct Sensitivity and Exploratory Analyses - Support Data and Safety Monitoring Board (DSMB) - Write Clinical and Statistical Reports - Prepare Global Submission of New Drug Applications (IND/NDA) We have applied an efficient process to manage multiple tasks and QA prior to database lock. Statistical analyses are completed within 1 day of database lock. Draft study report is written within 10 days of database lock. We have successfully passed all audits conducted by our clients.