Statistical Programming

Our Statistical Programming services include all programming activities for clinical study reporting as well as integrating studies for submission.  Specific services include:

  • Development of SDTM/ADaM datasets 
  • Production of Table/Listing/Figure for clinical study reports, publications and manuscripts
  • Validation and QC of dataset, programs of TLFs,  and submission packages
  • CDISC compliant submission data packages, including annotated eCRFs, define.xml, and reviewer’s guide
  • e-submission data packages
  • Mapping legacy clinical study data to CDISC compliant datasets
  • Integrated summary of safety and efficacy (ISS/ISE) analysis