Statistical Programming

At Resolutum Global, our statistical programming team provides customized programming solutions using the industry gold standard software, SAS®.​

All of our statistical programmers have vast experience producing tables, listing and figures for various therapeutic areas, trial designs and trial phases. Our team is experienced in implementing CDISC  standards to produce fully compliant SDTM and ADaM data packages that meet all of the requirements for electronic data submissions  to regulatory authorities.

We provide the following services:

• Tables, Listings and Figures for any report type.
• Exploratory and post hoc analyses including the pooling of multiple trial databases.
• CDISC data packages comprising of:
  • SDTM: Annotated CRFs, domain-level SAS® datasets and a define.xml including the Study Data Reviewer’s Guide.
  • ADaM: Analysis-level SAS® datasets and a define.xml including the Analysis Data Reviewer’s Guide.
• Legacy trial data conversions to CDISC standards.
• Outputs to support DSMBs, Data Monitoring or Safety Review Meetings, Development Safety Update Report and interim analyses.

 

Programming activities commence after the finalization of the SAP to ensure that results can be provided shortly after database lock. Our goal is to deliver draft tables, listing and figures within two weeks after database lock.​