SOFTWARE PROGRAMMING

Our primary programming tool for analysis and reporting is SAS Software. Standard macro utilities, code management and version control are programming practices used to insure accuracy and timely delivery of efficacy tables and listings and case report safety data tabulations. Our experience with programming across different data models and reporting algorithms has allowed us to anticipate the many programming exceptions that can occur across different protocols within single drug project.

• Case report tabulations based on ICH-E3 guidelines for inclusion in regulatory submissions -NDA/BLA/510k/sNDA and ISS/ISE
• Client specified table and listing formats for electronic document management
• Generation of SAS datasets per CDISC submissions meta-data model
• Adverse event and patient disposition tabulations of IND annual reports
• File format engines including XML
• Standard PK and laboratory data management and reporting systems.
• SAS utility macros and programming tools for client