Reporting and Analysis/Validation

Reporting and Analysis Services

• SAS Application Programming: Tables and Listing
• Standard Safety Report Development
• CDISC Reporting
• SAS Transport File Development and Validation
• Integrated Summary of Safety
• Integrated Summary of Efficacy
• Complete Biostatistical Services from Analysis Plan to Statistical Report

Data Validation and Auditing Services

• Database Quality Control Audits
• Program Validation
• Review of Data Listings and Tables
• Investigator Site Audits
• Clinical Study File Audits
• Clinical Study Report Review
• SOP Development
• Process Mapping