|
|
|
|
 |
|
All the projects, analyses and reports are based on ICH guidelines, on our Customers’ needs and on all internal and our Customers’ SOPs. Quality control methods are applied along all the phases of the projects.
 |
 |
Statistical input to protocol design |
|
|
|
Experimental design choice, sample size, randomization method and analysis plan. |
|
|
|
Random code generation |
|
|
|
The
random code is prepared by means of a SAS programme validated on the basis of the study design. |
|
|
|
IVRS  : Interactive Voice Response System |
|
|
|
It is a programmable telephone system, in operation 24 hours a day, which allows randomized centralization. |
|
|
|
Statistical analysis plan |
|
|
|
In the document, all the specifications for efficacy and tolerability analysis and the rules for the definition of the analysis set are reported in more detail than in the protocol. |
|
|
|
Interim analysis of efficacy and tolerability data |
|
|
|
The ongoing process management ensures the possibility to produce good quality interim analyses on the basis of planned needs or needs detected during the study. |
|
|
|
Statistical programming |
|
|
|
Programmes for statistical analysis are developed in SAS. Libraries of validated “core” programmes ensure their reproducibility. |
|
|
|
Statistical analysis and preparation of tables, graphs, listings and appendixes |
|
|
|
On the basis of the analysis plan and of relevant ICH guidelines (E3, E9), statistical tables, graphs and relevant listings are prepared according to the Sponsor’s requirements. The quality of the results is guaranteed by professional competence an by the accuracy of the checks on the documents produced. |
|
|
|
Statistical report |
|
|
|
It is a document that describes the statistical methodology employed and the results obtained. Its content is an integral part of the ICH report. |
|
|
|
Meta-analyses |
|
|
|
quantitative review, technique used to summarize the efficacy and tolerability results obtained with a drug in different trials. Meta-analysis is accepted by the Regulatory Board in order to improve precision of efficacy estimates; to evaluate efficacy in specific sub-populations of patients; to evaluate secondary efficacy variables whose assessment would require more power than the one obtainable with a single trial; to evaluate the incidence of rare adverse events in a large number of patients or tolerability in a sub-group; to assess lack of homogeneity of the results obtained in different trials. |
|
|
|
Statistical and methodological advice |
|
|
|
Its objects are study planning and the evaluation of the results obtained in published studies or specific topics. |
|
|
|
|
|
