General Information

The ZKS offers individualized advice and support in all aspects of

  • planning,
  • preparation,
  • realisation and
  • statistical evaluation

of clinical trials according to the international guidelines and quality standards of Good Clinical Practice (ICH-GCP). The working methodology of the KKS is regulated by Standard Operating Procedures (SOPs) that are harmonized with the national regulations and laws as well as international standards (ICH-GCP). A quality assurance system that adheres to defined quality standards on a procedural level is currently being designed.


What kind of Clinical Trials does ZKS administer?

In principle, all clinical trials may apply for supervision by the KKS provided that

  • clear formulation of study question
  • scientific and clinical relevance and
  • suitable design and methodology are to answer the study question

 

In particular, we are able to support the following studies:

  • Pharmaceutical products in phases I-IV of clinical testing
  • Comparison of clinical therapy with a pharmaceutical product to therapy forms without medication
  • Comparison of clinical therapy with a pharmaceutical product to a medical device products
  • Therapy optimization studies
  • Studies for the statistical comparison of diagnostic techniques
  • Observation studies (prognosis studies, second indication studies with scientific inquiry)
  • Population-associated studies for the determination of health risks

 

Our Services are available for:

Scientists and physicians, who conceive of a clinical study and would like to see it through in practice, but require local support (investigator initiated trials)

  • The University of Leipzig Medical faculty and University clinic
  • The academic training hospitals of the University of Leipzig
  • other universities
  • (Inter)national study groups
  • Public offices (Ministries, authorities), health insurance companies, medical associations and self-help groups that would like to initiate clinical studies
  • Pharmaceutical companies, which conceptualize a clinical trial and would like to see it through. (Industry initiated trials, that are required for the admission of a new medicinal product to the market)

 

Criteria for taking on a project

  • Scientific relevance (innovative)
  • Medical relevance (concerning diagnostic or therapeutic consequences)
  • Agreement with ethical principles, legal regulations, and international GCP standards (ICH)
  • Competence of the partner
  • Independent competencies (synergies)
  • Availability of resources
  • Requirements at co-operation partners

 

What we would like to expect of a Client

  • Clear delegation of responsibilities (e.g. scientific leader, principal investigator, project manager, etc.)
  • Readily available and reachable designated staff as well as a willingness to communication
  • Competence
  • Clearly organized method of operation
  • Reliability in patient recruitment
  • Complete documentation
  • Possibility of source data verification
  • No conflicts of interest

 

Last updated: 15-Jun-2015