Statistical Design Services and Programming

Theradex biostatisticians have a wealth of expertise in designing studies with the appropriate sample size and endpoints. At the protocol design stage, various scenarios can be accommodated in estimating sample sizes appropriate for a variety of assumptions. Assumptions include variations of endpoint differences based upon response rates, survival rates and improvements in overall patient well-being. The Theradex biostatistical and programming staff has broad experience in the planning and conducting of analyses for phase I, II, and III multinational studies incorporating many hundreds and thousands of patients. Theradex biostatisticians are also accustomed to ongoing dialogues with regulatory authorities to ensure concurrence in the appropriateness of analyses. These dialogues continue up through preparations for market approval. Additionally, the biostatistical and programming staff assist the medical writing and regulatory groups in the preparation of regulatory submissions and incorporate the necessary data tabulations for further regulatory analysis and graphical displays into sophisticated imaging media.

Theradex provides various biostatistical services including:

•        Randomization Plans and Computer Generated Schemes
•        Study Design and Protocol Development Consulting
•        eCRF Review
•        Statistical Analysis Plans (SAPs)
•        Data Safety Monitoring Board Charters
•        Statistical Programming Using SAS
•        Data Conversion
•        Data Standards
•        Statistical Tables, Data Listing, and Graphs for Clinical Study Reports (CSRs)
•        Sample Size Calculations
•        Statistical Consulting
•        Statistical Representation at FDA Meetings