Data management and statistics

Statistical data processing

For a valid evaluation of the study results, a solid data management system and the qualified handling of this is required.

We therefore offer:

• Sample size estimation/calculation, preparation of Statistical Analysis Plan (SAP) (internally or in collaboration with external statisticians)
• preparation of a data management strategy including data management plan, data validation plan and data management report
• Electronic data capture (we recommend our established EDC & CTMS system with full audit trail)
• Data evaluation and statistical analyses (internally or in collaboration with external statisticians)

On request, we can also support your study only with the preparaion of the eCRF. For this purpose, we use an ISO-certified and GCP-compliant EDC solution with full audit trail, train all study staff in the use of the eCRF for specific studies and act as a direct point of contact during the conduct of the study.