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 In parallel with the development of the protocol, we prepare a report outlining
the statistical methods to be applied and specifications for the presentation
of data (tables and charts). In tandem with the data management department,
we perform analysis to assure the quality of data, prepare statistical
material for case report forms and conduct analyses based on the plan.
We also handle requests for additional statistical analysis as data accumulates
through the trial. |
Data processing environment:
Our data are managed under strict quality control in accordance with GCP
compliant SOPs. We use the latest technology and computer systems, and
these are continually updated by our IT specialists. The maintenance and
control of the data processing system is undertaken by our specialized
Systems Engineers and the system is inspected regularly to assure reliability.
Data is processed biometrically using the latest software, including SAS,
to assure the quality of all analyses.
We offer the following:
- Development of statistical analysis plans (clinical trial design)
- Preparation of analysis plans
- Preparation of material for case review
- Preparation of analysis reports
- Preparation of case report forms
- Quality assurance of analysis results
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