STATISTICAL PLANNING
Omega Mediation may develop or review trial protocols from a biostatistical perspective. This contains adequate modelling in terms of choice of variables, analysis populations and statistical analysis methods as well as sample size planning.

Randomisation and development of emergency envelopes (in double-blind studies) may also be conducted by Omega Mediation.

STATISTICAL ANALYSIS PLAN (SAP)
Details of the planned analyses are fixed in a statistical analysis plan based on the study protocol. This document covers a detailed description of analysis procedures ranging from the definition of populations, conventions in deriving variables or imputing strategies and coding procedures up to the statistical methods applied. The SAP has to be finalised prior to database lock (or unblinding).

TABLES, FIGURES, AND LISTINGS
Based on SAS, all tables and listings are prepared as outlined in the statistical analysis plan. Standardised and validated macros will be applied, which enable e.g. a complete new run of programs within minutes including automatic numbering of tables. Comfortable PDF output files, incl. bookmarks for easy review, can be created. Usually, the statistical output will be presented prior database lock as "mock output", i.e. based on incomplete or not finalised data, in order to allow for comment on the layout during a non-time critical period.

REPORT
Based on a report template of either Omega Mediation or the sponsor, ICH conform reports will be created; PDF versions may also be generated. Either statistical reports or integrated reports can be drawn up. The default language is English.