data integrity
We explain how to ensure the data integrity of GCP-relevant computerized systems.
We provide consulting in the field of clinical research and development, both in process optimization and in the development of quality management systems. In addition, we support CROs, service providers and software developers in meeting the high demands on the validity of processes and data as well as the suitability of the software tools used.
Efficiency and cost control through process orientation and risk-based technology deployment
In the field of clinical drug research, the requirements for computerized systems and processes that support the setup, execution and subsequent evaluation of clinical trials are particularly high. On the one hand, patient safety is a priority during ongoing studies; on the other hand, the data integrity of the acquired data needs to be guaranteed. Both aspects (patient safety and data integrity) can be achieved through process-oriented quality management.
In particular, the development and application of technologies such as
- eCRF and EDC
- eSource technologies (e.g. electronic Patient Reported Outcomes – ePRO),
- IVRS / IWRS and
- eClinical platforms
represents a particular challenge. Heterogeneous system landscapes with many different (often non-standardized) interfaces and many users worldwide pose a high risk to the data integrity of the collected and processed data.
