Clinical Data Management
Our experienced Clinical Data Management team specializes in the development of trial databases and the cleaning of clinical data. With our customized solutions, we ensure efficient and secure management of oncology trial data - across different trial types and registries.
Our services in Clinical Data Management
We offer a comprehensive range of services relating to the planning, implementation and management of electronic trial data in secuTrial® - always clearly structured, user-friendly and in accordance with GCP guidelines.
Development and support of electronic case report forms (eCRFs) in secuTrial®
- Development and setup of eCRFs and trial databases
- Testing and validation of the database
- Hosting and maintenance of the trial database
- User administration and user training
Study-specific, GCP-compliant data validation
- Creation of trial-specific data validation plans
- Programming of electronic plausibility checks in secuTrial®-eCRFs
- Development of complex data validation routines in SAS®
- Implementation of structured data cleaning incl. electronic query management
Reliable processes and modern infrastructure for clinical data management
We use standardized Standard Operating Procedures (SOPs) for all processes in Clinical Data Management to ensure the highest quality and reproducibility.
Our electronic data capture system secuTrial®, hosted on the servers of the Swiss Cancer Institute in Switzerland, is fully GCP-compliant and validated according to the applicable regulatory requirements.
Efficient registry data management with the Swiss OncoData Infrastructure (SODI)
We have developed the Swiss OncoData Infrastructure (SODI) for registry projects. This is based on a common, semantically standardized core data set for oncology registries and enables us to create and manage registry databases and eCRFs in a structured and efficient manner - both cost- and time-efficiently.
Further information can be found here: SODI
Consulting
Are you still managing the clinical data of your studies or registry projects with confusing Excel spreadsheets or Access databases? Do you have difficulties with the data quality of your clinical studies or registries?
Our experienced Clinical Data Management team supports you in recording and managing your data in an efficient, structured and GCP-compliant manner - regardless of whether it concerns trials or registry projects.
Contact us - we will be happy to advise you personally.
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Jens Schulenburg
Head of Clinical Data Management