Department Clinical Trials


The core competency of the Clinical Studies Department is comprised of the organisation and implementation of clinical trials for pharmaceuticals and medical products (phases II-IV) and application observations in the disciplines of cardiology and cardiac surgery according to international research standards.

 

As a Site Management Organisation (SMO), the Department of Clinical Studies works as a partner for the pharmaceutical and medical-technical industry as a Contract Research Organisation (CRO) respectively. We recognize ourselves as a link between research and practise. The leading international manufacturers of medications and medical appliances rank among our customers.

 

Our organisational structure is based on two pillars: a central management and coordination of trials and interdisciplinary scientific teams in the centres. This is the basis for an efficient, flexible and high-quality trial culture for the clinical research.

 

Our well-qualified and highly motivated employees guarantee a fast and concise implemantation of complex and demanding trial projects that are compliant with the laws and the existing directives. They perform according to internal and external quality standards.

 

Support in planning, evaluation and publication of:

  • Therapy trials in phase II-IV of medical devices and/or pharmaceutical products
  • Application observations/registries
  • Diagnosis and prognosis studies

Implementation of:

  • Therapy trials in Phase II - IV with medical devices and/or pharmaceuticals
  • Diagnosis and prognosis studies
  • Application observations/registries

Project management:

  • Consultation with the ethics commitee
  • Proband insurance cover
  • Registration with the regulatory authority
  • Contract design and completion