With data management, we record and process your study data, thus ensuring the success of the subsequent evaluation. For this purpose, we work with databases tailored to your queries, which are validated before they are actively used for data collection. It goes without saying that we comply with the regulatory requirements of ISO 14155, GCP, 21 CFR Part 11 and DSGVO.
In the field of biostatistics, we support you in the selection of the optimal study design, in the calculation of the required sample size and in the statistical analysis of your data.
- Development of study documents such as statistical analysis plan, data management plan and data validation plan
- Case number calculation
- Development of the data entry form (Case Report Form [CRF]), (user) questionnaires and/or patient journals (paper-based or electronic)
- Selection and setup of the study database or EDC system
- User training and helpdesk for the use of an EDC system
- Query management (plausibility checks, comparison of data, e.g. between database and security messages)
- Coding of diagnoses and medications
- Descriptive and/or statistical analysis of data
We provide tailored support to meet your needs, whether it is a clinical study for a declaration of conformity of a medical device or a PMCF measure in as a part of post-market surveillance (PMS).
Phone: +49 7071 98979 - 139