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Biostatistics and Data Monitoring

Neox

We provide data and biostatistics monitoring to meet the varied clinical needs of our customers.

Data management

Neox offers data management to customers conducting experimental research in the various fields of life sciences.

Our data management is based on an electronic data capture (EDC) system. The EDC offers you paperless data collection with online query resolutions. Since there is no need for hardware or software installation, we can work according to your preferences. Studies can be set up in short time too, making the system highly cost-efficient, even for small studies. What’s more, automatic validation of data entry (edit checks) help to create accurate data faster, and the progress of the trial is easy-to-follow with real-time reports from the system.

Biostatistics

Our biostatistical services cover study needs from the planning stage, through to the reporting stage. Neox will generate the power calculations, as well as select optimal study designs and statistical methodology, all of which is documented in your custom statistical analysis plan (SAP).

Neox covers the statistical analysis of the study, providing you with statistical appendices, as specified in ICH guidelines. We will also assist you with the report writing process. Our tools and environment are compliant with FDA 21 CFR part 11, and are also corresponding to GCP and FDA’s guidance of computerised systems used in clinical trials.

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