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Data Management and Statistics
We cover every aspect of Data Management and Statistics, e.g. data entry, database design, data validation, statistics and consultation.
Case Report Form design
With our knowledge of the studies routine we can design Case Report Forms efficiently to get reliable data for primary and secondary endpoints.
Next to standard double data entry, the client can also choose between computerized data entry which may be excellent choice for Post-marketing trials, and computerized data entry with verification, which is much more time and resource efficient.
Database design, data validation, database lock
During the trial we can keep companies up to dated with their study’s progression by providing them with automated reports that are send by our Data Management System.
Prior, during and after a study many questions play a role. Before a study commences, we in Norma consult the company on the required population size to meet their targets, and review or write the section on the statistical considerations in their study protocol. During the study, we provide interim analyses. After the study, we may assist in analyzing the study data, assist in “translating” the statistical report and help in writing the final report.
Data Management Consultation
Next to data management services our Data Management department offer consultation on the data management process such as protocol review, and setup of SOPs for your starting data management department.