Clinical Data Management

Data collection at the site is either realized via eCRF or through paper-based CRF. A high-quality CRF design is essential for a perfect data structure but also for compliance at the site. This is where our CDASH-based data concept comes in.

Data recording by the subject/patient can be done using a paper-based or electronic diary. One should take note of our customized Notification App used in combination with the ediary. This combination will prompt the subject to collect the data and escalate the matter up to the investigator according to failures which can be pre-defined through a relevance assessment.

Optimal data quality is ensured by using automated as well as precise manual checks for plausibility and completeness (=edit checks) carried out by our experienced Data Management staff.

In order to resolve discrepancies in the data set, precise and comprehensible queries are issued to the site. Our experienced Data Managers take great care to ensure a good and efficient exchange with the study team and monitors/CRAs.

Our MedDRA or WHO-ATC / Drug Dictionary coding is always subject to a qualified review by the physicians and pharmacists in our team.

The assessment of study data in an interdisciplinary project team with well-structured data sets and documented decision-making processes by the involved Data Monitoring Committees - either during the course or at the end of a study - require well-established processes and experienced personnel.

Once all data management processes have been completed, the data is locked in a database, ensuring read only access to the data from this time on.

The SAS-based line listings are then used in a controlled process to create the complete Appendix 16.2 for the Integrated Clinical Study Report in accordance with ICH Guidelines.