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Pediatric… For Sponsors Single Point of Contact…

Single Point of Contact

Services

  • Communication and coordination between cooperation partners from the time of the study request from sponsors (e.g. from the pharmaceutical industry)
  • Clinical trial budget calculation
  • Clinical trial contract negotiations
  • Coordination and preparation of all necessary regulatory documents concerning trial center qualification (e.g. for Ethics Committee)

Contact

Mission

Efficient coordination, rapid organization and high-quality conduct of pediatric drug trials (Sponsor-Initiated Trials, SITs) from a single point of contact.

Background

During planning, organizing and conduct of pediatric clinical trials of early phases 0-2 as well as of challenging phase 3 trials, we work closely and interdisciplinary with our colleagues - pediatric experts (principal investigators) in the Center for Children and Adolescent Medicine. We are also connected with all other partners at the Heidelberg University Campus necessary for the successful realization of a specific clinical trial. These are, for example, the Coordination Center for Clinical Trials Heidelberg (Koordinierungszentrum für Klinische Studien, KKS), legal and third-party funding department, pharmacy department and central laboratory. The whole outstanding diagnostic infrastructure of Heidelberg University Hospital is available for this purpose.

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