Our Safety Management department at ZKS Cologne has many years of experience in the operational implementation of clinical trials, from first-in-human to phase IV. We offer you complete pharmacovigilance and safety management for your drug and medical device studies.

The spectrum includes investigator initiated trials (IITs) and industrially sponsored studies (monocentric / multicentric / multinational) in all indications. Quality-assured processes, qualified staff and comprehensive work instructions (SOPs) are available for this purpose. An ICH E2B-compliant safety database is used to record SAE reports, enabling integrated processing, MedDRA coding and electronic reporting to EudraVigilance. Thus we offer optimal conditions for a professional safety management of your clinical trial, in compliance with national and international laws and regulations and subsequently the best possible basis for ensuring the safety of your trial participants.

Our Safety Management services include:

• Advice on pharmacovigilance and safety management in the development of your study protocol and the conduct of your clinical trial
• Preparation and review of study-specific documents (safety chapter of the protocol, safety manual, serious adverse event (SAE) reporting forms, etc.)
• Entry of developmental medicinal products and substances in EMA’s XEVMPD database and its maintenance by registered users (also as Third Party Service Provider)
• Serious Adverse Event Management: receipt, documentation and complete processing of SAE reports: Tracking, query management, obtaining timely sponsor assessment, creation of narratives and case reports in CIOMS format
• Coding according to MedDRA and WHO Drug Dictionary by trained staff
• Reconciliation of clinical database and safety database (SAE reconciliation) and preparation of reports for interim analysis
• Timely processing and expedited reporting of SUSARs and other safety-relevant information to the competent authorities, ethics committees, Data Safety Monitoring Boards and investigators (CIOMS form or electronic reporting according to legal requirements and deadlines) and, if necessary, to manufacturing companies
• Support in the preparation of Development Safety Update Reports (DSURs) for drug studies as well as other periodic reports/listings for medical device studies
• Training of trial sites and generation of relevant documents (e.g. Investigator's handout) etc.
• Complete documentation of the relevant Trial Master File sections