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.