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Safety Management

Safety Support

Foto: Uniklinik Köln

The Safety Management Division of CTCC has years of experience in supporting clinical trials of all sizes (single-center / multicenter / multinational).

We offer a full pharmacovigilance management (consulting, planning, conduct) for investigator initiated trials (IIT) and industry-sponsored clinical studies in all indications. This comprises studies conducted under the German Medical Devices Act (MPG) or as well as the German Drug Act (AMG). A comprehensive quality management system and well-trained safety management personnel provide a high-quality workflow. For recording of serious adverse event (SAE) reports, CTCC uses an ICH-E2B-based pharmacovigilance data base that enables the management of individual case safety reports along with MedDRA coding and Eudravigilance Gateway in one central system. We ensure strict adherence to all regulatory guidelines, thus offering excellent prerequisites for the performance of clinical trials and for patient safety.

CTCC offers a full spectrum of services including:

Advisory service for planning and conduct of clinical trials with regard to pharmacovigilance and medical Monitoring

Composition and review of study-specific documents: Safety section of a study protocol, pharmacovigilance manual, Medical Monitoring Plan, SAE report forms, etc.  

Ongoing medical monitoring at study level during the trial:

Review of all available safety information, including signal detection and risk assessment

Provide periodic and ad-hoc safety reports

Provide training and support for clinical monitors, investigators and other study team members

Answer queries from sponsor, investigators, coordinators and clinical monitors review and assessment of protocol deviations

Medical review of coding and of medical information in the clinical database

Receipt, documentation, in-house medical review and complete processing of SAE reports (tracking, query management, obtaining sponsor’s assessment, MedDRA coding, narratives)

Reconciliation of SAEs Reporting of SUSARs and other relevant safety information to the appropriate competent authorities, ethics committees and investigators (Eudravigilance Gateway CIOMS form)

Reporting to involved manufacturers (if applicable)

Support/composition of Development Safety Update Reports (DSURs) and other periodic reports / listings

Cooperation with the Data Safety Monitoring Board

Support for investigators, e.g. training, additional information (investigator’s handout)

Team Safety Management

NameTitelFunctionFon +49-221-478-Fax +49-221-478-Email
Haddadi, Hedyeh Safety Management Lead882547984hedyeh.haddadi[at]uk-koeln.de
Büchs, Jochen Safety Manager881587984jochen.buechs[at]uk-koeln.de
Eggers, Kerstin Safety Associate882527984kerstin.eggers[at]uk-koeln.de
Facchinetti, ValeriaDr.Safety Manager881227984valeria.facchinetti[at]uk-koeln.de
Krema, Andrea Senior Safety Associate883907984andrea.krema[at]uk-koeln.de
Manjappa, KavithaDr. med.Safety Physician881417984kavitha.manjappa[at]uk-koeln.de
Pesch, CorinnaDr. med.Safety Manager855077984corinna.pesch[at]uk-koeln.de
Schmitz, BarbaraBScSafety Manager881307984barbara.schmitz[at]uk-koeln.de
Sherman, AnnaDipl.-Biol.Safety Associate881307984anna.sherman[at]uk-koeln.de