Division of Clinical Research

We support investigators from the formation of an idea for a clinical study up to the publication of results.

The division of clinical research supports clinicians but also companies, professional institutions and associations in the design, preparation and realization of clinical studies. Our support includes analysis and publication of the data. We work in close collaboration with physicians and manufacturers. In the surgical research network CHIR-Net (a BMBF funded organization) we cooperate with leading surgical centers in Germany.

Main Areas of Expertise

The division of clinical research at the IFOM has the main focus on surgical studies and the evaluation of the perioperative area with special experience in
  • medical devices,
  • health economics,
  • and wound healing.

Even though our main focus is on medical devices, we also have a longtime expertise in clinical studies with medicinal products and in diagnostic clinical studies.

We also support the development of online platforms to organize your study or to create training tools.

Networking

ZKS-UW/H

The ZKS-UW/H (Center for Clinical Studies, Witten/Herdecke University) coordinates already established structures at UW/H for the realization of clinical trials. It comprises the management and five supporting institutions, one of which is the IFOM, located in Cologne/Merheim.

ECRIN

ECRIN is a not-for-profit, EU-funded institution which supports multi-national clinical research projects. It provides information as well as consultation to investigators and sponsors in the preparation and conduct of multinational clinical trials with medical devices.

CHIR-Net

The surgical study network was founded in 2006 and was funded by the German Federal Ministry of Education and Research until 2014. The common goal of 14 regional CHIR-Net centers is the promotion of patient orientated surgical research.

Services

Planning and Preparation of Clinical Studies

  • Scientific evaluation of study concepts
  • Feasibility check (ethical, financial, formal and content)
  • Support in regulatory affairs (Ethics committees, notified bodies, study registration)
  • Biometrical planning and SAP design
  • Study protocol development according to GCP, ISO 14155
  • Planning of necessary resources and infrastructure

Conduct of Clinical Studies

  • Organization of national and international clinical trials
  • Project management
  • Monitoring
  • Data management
  • Assistance in patient recruitment and documentation at study sites (Flying Study Nurse concept)

Analysis of Clinical Studies

  • Statistical analysis and report
  • Writing of final reports
  • Creating presentations and presenting data at scientific meetings