Safety Management

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.

CTC Cologne 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.
  • 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)

For more specific information please contact:

Hedyeh Haddadi, Team Lead

CTCC Safety  Management
Phone: +49 221 478 88254