Biostatistics

Trial design

Our team can advise on a wide range of trial designs, using publications and guidelines helping the sponsor to translate hypotheses into industrial risk. Our experiences include the design and implementation of equivalence/non-inferiority trials and the development of sequential and adaptive designs. We also help sponsors to take into account important stratification factors (see section randomisation for further details).

Analysis plan

The analysis plan covers population/dataset definition, missing values management, primary and secondary hypotheses description, statistical tests, associated assumptions and algorithms used. Furthermore an appendix to the plan contains key tables/graphics which will be included in the report.

Programming procedures and CARDS©

CARDS© is the acronym for Computer Aided Report Delivery System. It is a group of methods and programs which permit us to generate, from statistical analysis softwares, document elements to be included in text processors or professional publishing tools. These elements including tables, listings and figures are already enriched/formatted and contain the logical information needed by the target product to make automatic cross-references or links, paragraph numbering and the table of contents.

This approach permits us to program in advance components of ISS/ISE or ICH E3 reports which remain dynamically linked to the frozen databases thus guaranteeing consistency in the results.

Domains of expertise

With over 10 years of experience Cardinal Systems biostatisticians have acquired expertise in the following fields: