Project Management

Tasks and services at a glance

We take over the project management of your clinical trial and thus control and coordinate everything from preparation to analysis of your project.

We support you in the organisational implementation of all types of clinical research projects, such as studies with drugs or medical devices, surgical studies, studies on rare diseases or the creation of registries.

Depending on the agreed range of services, we coordinate the practical implementation of your study, from study idea to publication, or take over defined aspects only.

For a specific project, the CTC Cologne project management is your central contact. We provide you with expert advice on the practical project implementation and coordinate the CTC Cologne departments as well as other involved divisions of the University Hospital and/or external cooperation partners at all study stages.

Our range of project management services at CTC Cologne includes:

General tasks

• Central contact person for you as the client
• Assumption of full project management or agreed partial aspects, including coordination, surveillance and internal quality assurance of all agreed tasks
• Implementation of risk-based quality management in accordance with applicable regulations
• Set-up and maintenance of the Trial Master File

Study preparation

• Development and/or review of study protocol as well as other project-specific documents or all study-relevant materials, depending on the agreement
• Conclusion of patient insurance
• Take over of tasks related to the clinical trial application by the regulatory authority / ethics committee(s) / other authorities involved

Conducting the trial

• Briefing, coordination and management of the respective study team (national and international)
• Surveillance of study progress (e.g. recruitment of patients) as well as planning and implementation of appropriate countermeasures in case of non-adherence to the time schedule
• Quality assurance of the project and optimisation of the project process
• CTC Cologne internal resource and financial control during the course of project

Study completion

• Collaboration on final reports and publications
• Deregistration of the study and submission of study results to regulatory authorities / ethics committee(s)
• Archiving preparation of all project-specific documents after completion of your project.

Team Project Management

University of Cologne as sponsor of clinical trials

Please inform yourself about procedures in case of working with the University of Cologne in the function as sponsor.  

Link to Qualitätssicherung Medizinische Fakultät

Please note: