Study design and Consultancy
Biomarker study design
In every study, the design is key. It is particularly true in exploratory biomarker studies, where statistical power cannot be controlled and where sample logisitics can have an important impact on input data quality and availability.
Quartz Bio data scientists have analysed numerous biomarker studies and have experienced many cases where design flaws impacted negatively the analysis.
This expertise is routinely used a posteriori in the Quality Control process, but could also better be used before generating the data, i.e. at the design stage. Thus, reviewing the exploratory part of the Clinical Study Protocol and affiliated documents such as Analytical Plans or Manual of Operations could permit optimising the biomarker study design.
Numbers are nothing without the biology which is behind. All our projects are analysed from a biological perspective.
As the data scientists analysing your data, we are in the best position to support the publication of your results (patents, posters, articles). We generate customised figures, tables, and listings that bring out your data.
A picture is worth a thousand words. This is particularly true for complex biological data. Drawing constructive conclusions from a biomarker analysis requires adapted visualisation methods, aligned to the objectives of the analysis. We use our biotechnological and computational expertise to provide the best graphical representation for your data.
Statistical Analysis Plan (SAP)
The SAP is the blueprint of the analysis that will be performed.
Before each analysis, a SAP will be written describing:
- The objectives of the analysis
- The data that will be used
- The methods used
- The output (tables and plots) that will be generated
The writing of a SAP is of common practice in clinical trials and obeys to specific standards.
All exploratory data analysis projects must be inherently flexible and allow room for innovation and unexpected results.
We implement this flexible approach in the writing of the SAP. During the analysis we will document and report all potential deviations from the initial analysis plan.
You have a project in mind and need support for its design?
Our experts are available to answer your questions