Statistical Programming

Our experienced statistical programmers generate CDISC-compliant datasets (SDTM and ADaM) and statistical outputs (TLFs) that follow the Statistical Analysis Plan. The group is also involved in the preparation of outputs for safety reviews for on-going studies,annual regulatory reports, and preparation of integrated documents for regulatory filing.

• CDISC Standards – Regulatory agencies require that all studies for submission meet the SDTM and ADaM standards. Our programmers have in-depth knowledge of handling any study data and turn them into these standard datasets efficiently. We also prepare documentation for the regulators that show traceability of the data from raw datasets to statistical outputs. Our services include

⨀ Create customized CDISC solutions

⨀ Create CDISC SDTM domains from client-defined data standards

⨀ Ensure compatibility with any version of the SDTM Implementation Guide

⨀ Program SDTM and ADaM datasets from raw data 

⨀ Map studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission

⨀ Create Develop Submission-Ready Documents, Packages and Reviewers Guides (DEFINE.XML)

⨀ Create ADaM domains to support TFLs and maintain data traceability from CRF to CSR (mapping documents)

⨀ Provide Centralized Data Storage/Metadata Repository

• Programming of Outputs – Our programming team works closely with the study statisticians. Questions from the protocol and SAP are thoroughly understood before programming of the analysis datasets, tables, listings and figures (TLFs). At Inference all outputs go through a 3-step QC process including double-programming.  We ensure that the outputs are based on accurate data derivation, and follow the protocol, SAP, programming specs, and mock shells. The QC ends with a thorough review from the statistician who ensures that the results make sense in the context of the trial.