Statistics is regarded as one of the core disciplines of pharmaceutical research, which relies on the collection of objective data to demonstrate clinical effect. Biostatistical consulting covers issues from study design and strategies, to the analysis of study data and informed interpretation of results. The benefits of Statistical Consultancy are:
An optimally designed trial can reduce your costs and save time, either by requiring a smaller sample size or by stopping a trial earlier in time without continued wasted efforts. Our highly skilled statistical consultancy team will ensure your study is designed to meet regulatory requirements for approval or post-submission, and can support you with:
These sources requires specific methods and an understanding of Observational Studies to ensure the correct conclusions are drawn. Plan the correct analytical methods to deal with these data sources and ensure all potential source of bias are identified and properly managed.
The definition of a study estimand is a crucial part of study planning since it specifies the scientific question of interest. Define the correct study estimand by liaising with your clinical team to ensure you specify all components are consistent with the current regulatory framework.
Karen Ooms is responsible for overseeing the Statistics department at Quanticate. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years.