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Data Management at CTCC

Services at a glance

CTCC offers you, our client, complete services of GCP-compliant Data Management processes for clinical trials with electronic CRFs.

Our Clinical Data Management System is validated according to regulatory requirements. We have implemented quality assurance and quality control processes to produce secure and valid data for statistical analysis.

Our services include:

  • eCRF Design
  • Preparation of Data Management Manuals, Data Review Plans, Data Entry Guidelines, Reconciliation Manuals etc.
  • Study Database setup, validation and maintenance (including comprehensive plausibility checks)
  • User training comprising eLearning and help desk
  • Data cleaning and query management
  • Study specific reports online or through scheduled mailing
  • Email alerts on events, e.g. “new patient” or “new SAE”
  • Coding (MedDRA, WHO-DDE)
  • Management of lab data
  • SAE reconciliation
  • Database closure and data export
  • CDISC SDTM mapping

Team Data Management

Name Function Fon +49 221 478- Fax +49-221-478- Email
Leyendecker, Ingrun Lead Data Management 88132 87887 ingrun.leyendecker[at]zks-koeln.de
Bergmann, Ulrike Data Manager 88139 87887 ulrike.bergmann[at]zks-koeln.de
Grünwald, Irene Data Manager 84870 87887 irene.gruenwald[at]zks-koeln.de
Hannig, Anna Data Manager 88147 87887 anna.hannig[at]zks-koeln.de
Kümmelberg, Sandra Data Manager 88142 87887 sandra.kuemmelberg[at]zks-koeln.de
Pfeiffer, Andrea Data Manager 88133 87887 andrea.pfeiffer[at]zks-koeln.de
Scheckenbach, Frank Data Manager 88257 87887 frank.scheckenbach[at]zks-koeln.de
Schwartzkopff, Franziska Data Manager 84872 87887 franziska.schwartzkopff[at]zks-koeln.de
Willms, Sandra Data Manager 88134 87887 sandra.willms[at]zks-koeln.de
Lukiewicz, Izabela Data Entry 88139 87887 izabela.lukiewicz[at]zks-koeln.de