Data management at Winicker Norimed
The link between patient data and statistical results
Our data management team consists of dedicated and experienced data managers and coders. The close cooperation of the data management and biometry departments as early as in the planning phase of a study ensures that the final statistical evaluation is based on complete and reliable data. Independent of a subsequent statistical evaluation, you can also benefit from our data management services separately.
Our range of services
in data management
- Development of eCRFs and paper CRFs
- Database development (including audit trail) in accordance with standards set by the sponsor or the CDISC standard
- Creation of data management and data validation plans
- Data acquisiton
- Review of data privacy breaches (GDPG) and hidden adverse events
- Data validation and query management
- Comparison of serious adverse events with the safety database (reconciliation)
- Event coding according to standard codebooks (MedDRA and WHO DDE)
- Data export after closing the database (on request also periodically)
Your contact
for data management
Dipl. Statistiker
Stefan Bruns
Head of Biometry
stefan.bruns@winicker-norimed.com
+49 (0) 911 / 92680 – 8623
Winicker Norimed GmbH
Deutschherrnstraße 15-19, 90429 Nuremberg
Phone: +49 (0) 911 / 9 26 80 – 0
Fax: +49 (0) 911 / 9 26 80 – 8839
E-Mail: wn@winicker-norimed.com