After all the basic information was made visible with the help of generation of tables, graphs and listings, a clinical study report should be created.
Our main strength in it that data (information) is not typed from TLG into the statistical report, but the study report is also generated by the same programs which generated the outputs. With this approach we can decrease of potetial typing/copying errors to 0%.
The reamining risk of bias, that is the potential programmatic errors are managed carefully: both the program code and the output is checked by a dedicated quality assurance team.
In reporting we are following the ICH (The International Council for Harmonisation) guidelines.
Phase III study in oncology for a Swiss pharma company.
Phase II dose finding study in kidney disease for a Swiss pharma company.
Pilot study in hepatitis B for a Canadian pharma company.