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Services for industrial partners

At the Leipzig University Medical Centre (UML), industrial partners find optimal conditions for the implementation of clinical research projects with diverse clinical and best infrastructural possibilities. An overview of the study-active clinics or research departments of UML is provided here.

OUR RANGE OF SUPPORT

The Site Management at the ZKS offers support for clinical studies at the UML in the following areas:

  • Quality management (SOPs, preparation of audits / inspections)
  • Staff training (e.g. information and training events and media)
  • Study preparation and administration (management of feasibility inquiries, calculation of study costs based on visits and procedures, IT infrastructure)
  • Execution of studies by flying study nurses (documentation of patient visits, management of the ISF, visit planning, administration of investigational medicinal products, patient care and patient recruiting)

OPTIMAL CONDITIONS FOR CLINICAL TRIALS

  • Clinics with extensive study experience at the Leipzig University Medical Centre
  • High-performance infrastructure including pharmacy, laboratory, pathology, nuclear medicine, radiology, biobank
  • Fast communication through close networking of all study-active clinics and administration
  • continuously qualified investigators, lead investigators and study assistants (ICH-GCP, AMG)
  • Central and standardized administrative support of all clinical studies conducted at Leipzig University Medical Centre by the Administrative Study Management (ASM)
  • An established quality management system including SOPs, internal evaluation and audits
  • Use of IT-supported study infrastructure
  • With feasibility enquiries we immediately address our respective contact persons in the UML clinics and give potential partners prompt feedback
  • High patient recruitment potential through efficient study units in the clinics
  • Instruments for targeted patient recruitment

QUALITY CONTROL

  • Implementation of all international quality standards of Good Clinical Practice (ICH-GCP)
  • Establishment and maintenance of Standard Operating Procedures (SOPs) in the UML trial centres to ensure appropriate quality standards for the conduct of clinical trials
  • Implementation of internal audits, preparatory support for sponsor audits and inspections
  • Quality assurance and improvement through training of medical and non-medical study staff of the UML clinics

Do you have questions about our services or need support?

Please contact us: E-Mail Adresse