Statistical Programming

Statistical Programming…

… means the collection of activities from database closure till we derive the Study tables, listings and graphs.

This includes:

  • SDTM and ADaM mapping (application of CDISC standards in short),
  • generation of Define.XML and Define.PDF,
  • preparation of unique tables listings and graphs (TLG),
  • preparation of repeated TLG.

During statistical programming we maximally concentrate on quality assurance with keeping programmic standards, application of strict review of the ready-to-validation codes and with thoughtful checking of the output against the table shell instructions.

    References

    Phase I Cross-over clinical study with a NSAID for a French pharma company.

    Phase II study in haematology running in 8 European countries for an UK pharma company.

    Phase II clinical trial in infection for an UK pharma company.