Biostatistical Programming

 

Our statisticians have experience across most therapeutic areas, have produced numerous publications, have been a part of numerous data monitoring committees, and are members of American Statistical Association. 

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You may not need a full-time biostatistician

But you still need specialized expertise.

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Our stats experts primarily fill roles including:

• Providing expert statistical consultation

• Authoring or contributing to manuscripts and/or scientific presentations

• Collaborating with clinical investigators to determine study design

• Development of statistical analysis plans and programs to perform analyses and display study data

• Development of statistical analysis data sets, in compliance with CDISC standards

• Performing statistical analyses; writing and validating application programs

• Implementing data and safety monitoring reports to ensure participants’ safety

• Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center

• Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies including Data and Safety Monitoring Board reports, IND annual reports, and Clinical Study Report

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The deep expertise of our TradeCraft Biostatistics Team has supported clinical trials from 1) study design and protocol development to 2) analysis and reporting. We empower our clients lean on this expertise as the right choice for ensuring that protocol integrity is reflected in the design of the trial, that all data collection tools are aligned, and that data quality is prioritized throughout the process. Combining these practices improves the data life cycle and offers the greatest value to clinical research teams.

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Our precision, speed, and flexibility maintain the integrity of a clinical trial while improving communication among clinical research team members. 

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