Stat Programming – inference Inc.

STATISTICAL PROGRAMMING

The Pulse of Any Clinical Study are the Statistical Programmers.

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.

Services Include

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.

Therapeutic Areas

Oncology:

CDISC Submission ready packages – SDTM with focus on TD, TU, TR and RS domains. ADaM with focus on ADTR, ADRS and ADTTE analysis domains

•Experienced with data for multiple categories such as RECIST, iRECIST

ISS/ISE Experience – Solid Tumors (Gastro, NSCLC/SCLC, Basal Cell Carcinoma), Blood Cancers

Strategic considerations:

•Reconcile RECIST data (eCRF collected) programmatically against investigator response data to ensure responses are managed correctly, ensuring the integrity and reliability

•Concordance of data between Investigator response and Blinded Independent Committee Review (BICR) response data