Data management and Biostatistics

With our data management service, we take care of the high-quality collection and processing of your study data, thus ensuring the success of the subsequent analyses. For this purpose, we use validated databases tailored to your our specific research questions. Naturally, we comply with the regulatory requirements of ISO 14155, ICH-GCP, 21 CFR Part 11, and GDPR.

In the field of biostatistics, we support you on selecting the optimal study design, implement it together with you, and, if needed, perform the calculation of the required sample size and the statistical analysis of your data.

Preparation of study documents such as the Statistical Analysis Plan (SAP), Data Management Plan (DMP) and Data Validation Plan (DVP)
Sample size calculation
Setup of the Case Report Form (CRF), (user) questionnaires, and/or patient diaries (paper-based or electronic)
Selection and setup of the study database or electronic data capture system (EDC system)
User training and helpdesk for the use of an EDC system
Query management (plausibility checks based on the DVP, data reconciliation e.g., between the database and safety reports)
Coding of diagnoses and medications
Programming of descriptive and inferential statistical analyses of the data using an established analysis program according to the SAP
Data analysis and preparation of a Statistical Analysis Report (SAR)

An external perspective on the data can provide new impulses, which may lead to the development of new research questions. We help you get the most out of your data.