Statistical Programming

At Kinesis, programming team is built with expert programmers who had expertise in handling all phases of clinical trials. Our team is experienced in implementing CDISC standards and can produce fully compliant SDTM and ADaM data packages that meet all the requirements for electronic data submissions to regulatory authorities.

Team Kinesis can deliver:

  • SDTM packages, constituting of Annotated CRF, SDTM compliant SAS® datasets, Specifications and define.xml along with SDRG.
  • ADaM packages, comprising of Analysis level SAS® datasets and a define.xml including the Analysis Data Reviewer’s Guide.
  • Legacy study data conversions to CDISC standards.
  • Tables, Listings and Figures.
  • Validation of deliverables by implementing double programming.
  • eCTD Submission & post Regulatory Queries Support.