At WCCT Global, we know the importance of providing an experienced team and biostatistics. We also know the importance of providing cost sensitive solutions to the Pharma and Bio-tech industry. That is why we offer 2 distinctly different models when it comes to Statistical Services. Being a global company, we have the ability to offer on shore or off shore model when it comes to Statistical Services. Both models provide the same types of services, all lead by our internal people, processes and quality.
WCCT can provide biostatistics services for conducting all activities associated with data summarization and/or statistical displays of the study. It is a collaborative approach : WCCT and the study sponsor will collaborate on the development of a Statistical Analysis Plan (SAP). The biostatistician will also review the study protocol and provide, or review, the protocol description of a statistical analysis of the study data appropriate to the study objectives. The biostatistician will review the sample size of the study to advise the sponsor regarding its adequacy for achieving the protocol objectives.
The Statistical Analysis Plan (SAP) will includ a detailed description of the targeted study population and statistical methodology to be used, methods of computation of all analysis variables, handling of missing values and outliers, handling of multiplicity issues, identification of primary and secondary analysis variables, identification of analysis populations and subsets, and methods to ensure blinding and control of Type I error rate for any interim analyses. The SAP will also include templates or formats for proposed summary tabulations of the data and data listings to be included in the clinical study report. The SAP will include data definitions for all analysis data sets not already described in the Data Management Plan.
The biostatistician will author a test programming code for preparation of tables, listings, and figures, and performance of statistical analysis of the study data according to the SAP. The biostatistician will perform an independent statistical review of the clinical database and provide review comments for resolution to the CDM prior to database closure. After the authorized database lock, the biostatistician will merge the randomization codes, and develop the planned tables, listings, and figures. WCCT QA will perform an independent audit of the tables, listings, and figures, to confirm their correspondence and agreement with the SAP and the study database.
The biostatistician will collaborate with the medical writer to ensure that statistical methods and results, and any changes in statistical methods or special circumstances, are properly related in the clinical study report