Project Consulting & Planning

Tasks and services at a glance

The Project Consulting & Planning team is available to all interested parties from the Medical Faculty of the University of Cologne, but also to external interested parties, for advice on the content, planning and cost calculation of clinical trials. We advise on all services offered by the CTC Cologne for trial planning and operational conduct. For members of the Medical Faculty of the University of Cologne, our consulting services are free of charge up to a volume of 40 hours.

In close cooperation with our operational team leaders, we support you in the planning of all types of clinical trials, such as trials with drugs or medical devices, surgical trials, trials on rare diseases or in the design of registers. Depending on your needs, the CTC Cologne can put your complete trial into practice, from the initial trial idea to publication, or manage partial aspects for you only. You can select the support suitable for your project from our service portfolio.

If you need support with a specific project, we will be happy to support you with our competent team. We will advise you on the specific requirements, plan the project with you and, based on our agreements, draw up a cost calculation and an offer for the services you require from the CTC Cologne or for the project as a whole. With our broad experience, we can support you also with applications to public funding bodies such as the Federal Ministry of Education and Research (BMBF), the German Research Foundation (DFG), Cancer Aid/Children's Cancer Aid or the Federal Joint Committee (G-BA).

Make an appointment with us! We will be happy to meet you at your office, advise you here at the CTC Cologne, or in an online meeting.

To make an appointment: Phone +49-221-478-88147 or E-Mail projektplanung(at)zks-koeln(dot)de

Our range of services for project consulting and planning at the CTC Cologne includes:

• Planning of clinical trials with regard to feasibility, conception and design, GCP conformity, regulatory classification and administrative aspects, quality assurance, sponsor function, cooperations, financing and cost planning, operational management.
• Assessment of monitoring needs on the basis of the evaluated study risks
• Financial planning of the project, preparation of partial or full cost calculations
• Assistance in the acquisition of third-party funding (funding applications)
• Support in negotiations and contract agreements with sponsors
• Advice in the context of the University of Cologne's sponsorship activities
• If required, GCP consulting for clinical studies
• Advice on collaboration with cooperation partners and the establishment of study committees
• Planning and coordination of the tasks of the CTC Cologne within a clinical trial and documentation of responsibilities (Task Allocation List)

Team Project Consulting & Planning

Services in figures

We consult on about 70 new enquiries on research projects per year.

University of Cologne as sponsor of clinical trials

Find out about the process if the University of Cologne is to act as sponsor (according to §4 (24) AMG (German Medicines Act), or Article 2 (49) MDR (Medical Device Regulation), or § 3 MPDG (Medical Device Implementation Act)) of your trial.                       
University of Cologne as Sponsor for Clinical Trials