As a Gold Partner of SAS Institute we have seen and worked with many recent and legacy solutions, including SAS Studio, Enterprise Guide, SAS Drug Development (SDD), Life Sciences Analytical Framework (LSAF) and of course the Enhanced Editor.
R is becoming more popular in industry and has many supporting modules for statistical models and graphics, but regulation within the life-science industry demands high levels of software validation in connection with the use of the open source software.
Tables, Listings & Figures (TLF)
Abbreviated as TLF these are core components to any clinical trial report and submission. Our statistical programmers are experts in the efficient development of TLF that are easy to read and interpret.
With descriptive statistics we provide simple yet essential summaries of clinical data. Whether in tables or graphs, these summaries will form the basis for both the initial description but also the extensive analysis of the clinical data.
To be sure all deliverables are of good quality we perform validation. The level of validation is dependent on the importance and complexity of the deliverable.
Statistical Analysis Plan
Abbreviated as SAP, a statistician creates this document together with a clinical researcher and statistical programmer. The SAP is a detailed description of how to analyse clinical trial data, based on the objectives and the available trial data.
Combining results from several separate studies might improve precision, power and settle controversies around conflicting claims, but could however be misleading when combined trials differ in design, so always consider within-study bias or variation across studies.
Based on the assumptions of a clinical trial, statistical modelling is used to approximate reality and make predictions from the approximations. Our statisticians have expertise in a wide variety of commonly used statistical models.