Strengthening Patient-Oriented Clinical Research
IZKS has been founded in 1999 in order to strengthen patient-oriented, clinical research at UMC under its former name, Coordination Center for Clinical Trials Mainz (KKS Mainz). From 2007 to 2015, IZKS received funding as one out of five “coordination centers for clinical trials” at German universities by the Federal Ministry of Education and Research (BMBF). The funding has been provided to optimise clinical research and strengthen Germany as an important research location within the medical care area.
Focussing on clinical and Health Care Research
According to our mission of providing the best possible support in organising and conducting clinical trials, IZKS has developed profound expertise within the full range of clinical research as well as health care research. Beside supporting numerous clinical trials with medicinal drugs and medical devices, including digital device projects, IZKS also created and operates registries for severe asthma, chronic heart failure, cystic fibrosis and haematological oncological diseases, ensuring also facilitation of state-of-the-art information technology. The working procedures are dedicated to warrant valid and reliable data during research in order to support development of effective treatments and assuring adequate corresponding medical care for patients. Additionally, IZKS offers certified trainings to investigators, scientists, study nurses, clinical research associates and medical students on a regular basis.
Delivering Scientific and Systematic Clinical Trial Support
IZKS supports clinical trials with scientific and systematic excellence and delivers quality-oriented support to clinical researchers and scientists as well as public institutions and companies planning to conduct an Investigator Initiated Trial (IIT) or a Sponsor Initiated Trial (SIT) − starting with the study idea to the publication of results. In the course of planning a clinical trial of particular importance, IZKS supports application procedures for public funding as well as acquisition of industry funded clinical trials. IZKS services also cover the development of a clinical trial concept, efficient execution of the clinical trial including all necessary tasks and, furthermore, comprehensive data analysis and statistical evaluation. Upon request, IZKS offers to take responsibility for the entire clinical trial coordination, including all transferable sponsoring tasks, furthermore technical and scientific steering of product development for medicinal products and medical devices.
- Professional, GCP compliant consulting, planning, coordination, evaluation and publication of clinical trials in accordance with all applicable legal requirements
- Profound expertise of all relevant national and international regulations (e.g. ICH, Medicinal Products ACT (AMG) and Medical Device Act (MPG)
- Well-established quality management
- Efficient IT support for individual solutions
- High-quality data centre certified by ECRIN
- Organisation of certified trainings and seminars; organisation of in-house trainings upon request
Excellent Employees, Partners and Collaborations
- Experienced and dedicated personnel
- Strong partners, e.g. UMC Pharmacy (medical manufacturing authorisation according to §13 German Drug Law (AMG)); Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI); Central Laboratory
- Closely connected to all clinical departments and institutions of UMC and its academic teaching hospitals
- Collaboration with numerous academic and non-academic hospitals, private physicians, public health organisations and pharmaceutical and medical device industry partners in and outside of Germany
Qualification of Clinical Research Personnel
IZKS offers certified trainings and seminars, e.g. for investigators, scientists, study nurses, monitors and medical students and furthermore in-house trainings upon request. Our trainings are certified by the Bezirksärztekammer Rheinhessen and approved by the Ethics Commissions in Germany.