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.
Relevant experience:
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 clients
QUARTESIAN ADVANTAGE
Cost-effective full-service model for Phase I studies
Unmatched statistical and programming capabilities
Responsive, personalized service
Key professionals lead every project from planning to delivery
