Information for Clinical Trial Sponsors

University Hospital Martin’s Clinical Trials Department offers administrative and organizational support to sponsors and investigators throughout the clinical trial lifecycle.

For inquiries about conducting a clinical trial at our institution, please contact us via email at klinicke.skusanie@unm.sk or by phone at +421 905 231 194.

Scope of Administrative Support Provided by the Clinical Trials Department:

Feasibility Assessment:

  • Facilitation of Confidentiality Agreement (CDA) signing.
  • If a preferred principal investigator (PI) has not been designated, we consult the trial’s feasibility with a relevant medical expert and recommend a suitable PI.
  • The appointed PI is always an experienced physician trained in Good Clinical Practice (GCP).
  • A minimum of a protocol synopsis is required for feasibility evaluation.

Pre-study Visit:

  • During this visit, we provide the PI’s CV and GCP certification.
  • Key aspects of the study protocol, study team composition, involvement of additional departments (e.g., imaging, laboratory services), storage and handling requirements for the investigational medicinal product (IMP), and biological sample processing and storage are reviewed.

Start-up Phase:

  • We provide administrative assistance with contract and budget negotiations, study team formation, and the completion of necessary documentation and certifications.

Site Initiation Visit (SIV):

  • The SIV is scheduled in agreement with the PI and study team members. Prior to the visit, the following prerequisites must be met:
    • Regulatory approval of the clinical trial.
    • Execution of a formal contract between the sponsor and University Hospital Martin (or finalization of contract terms).
    • Delivery of all essential study materials (protocols, documentation, laboratory kits, etc.).
    • Ensuring study team members have the necessary access to required electronic systems.

Ongoing Clinical Trial Monitoring:

  • We provide administrative support for certificate renewals, documentation of IMP and biological sample storage, and coordination of invoicing.

Trial Completion and Site Closure:

  • We assist with all administrative procedures related to site closure, including the return of unused materials to the sponsor or on-site destruction if required.