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Clinical Monitoring

Gateway between study team and sponsor

Monitoring is a quality control tool to ensure the integrity of trial data and the protection of the rights and the well-being of study participants.

The monitor links the study team with the sponsor. Monitors check whether study activities are according to protocol, GCP, SOP and regulatory requirements. Thus deficiencies can be identified and improved. To reach these goals with adequate resource utilization, we adapt monitoring intensity to the estimated risk a study bears. Your specific trial will receive a tailored monitoring approach. 

We provide the following services:

  • Review of the study protocol with respect to the described monitoring activities
  • Preparation of trial specific monitoring plans/manuals
  • Monitoring of the conduct of clinical trials (site selection-, initiation- , regular-, and close-out visits), in order to oversee data collection, review source documentation and case report forms, ensure regulatory compliance and resolve data queries.
  • Advisory services and training for investigators and study teams on study protocol and study conduct. 

Team Monitoring

Name Function Fon +49 221 478- Fax 478- Email
Staß, Angelika Monitoring Lead 88137 88209 angelika.stass[at]zks-koeln.de
Fassihianifard, Faranak Monitor/CRA 88150 88209 faranak.fassihianifard[at]zks-koeln.de
Hayn, Birgit Monitor/CRA 88124 88209 birgit.hayn[at]zks-koeln.de
Helfer, Gabriele Monitor/CRA 88146 88209 gabriele.helfer[at]zks-koeln.de
Oleszko, Martha Monitor/CRA 88259 88209 martha.oleszko[at]zks-koeln.de
Paus, Martin Monitor/CRA 88210 88209 martin.paus[at]zks-koeln.de
Scharfenberger, Lukas Monitor/CRA 88136 88209 lukas.scharfenberger[at]zks-koeln.de
Schmeling, Fabian Monitor/CRA 88206 88209 fabian.schmeling[at]zks-koeln.de
Schröder, Annika Monitor/CRA 84920 88209 annika.schroeder[at]zks-koeln.de
Steinfeld, Valentina Monitor/CRA 88149 88209 valentina.steinfeld[at]zks-koeln.de
Wicharz, Margarete Monitor/CRA 88253 1001 margarete.wicharz[at]zks-koeln.de
Yilmaz, Selma Monitor/CRA 88258 88209 selma.yilmaz[at]zks-koeln.de