Pediatric… For Sponsors Quality…

Quality management


  • paedKliPS has been certified for the planning and conduct of clinical trials with children and adolescents according to the quality management (QM) standard DIN EN ISO 9001:2015 since October 2019. Thus, the unit meets the highest quality standards.
  • The modular QM software roXtra is used.
  • Regular internal and external audits guarantee the maintenance of our quality standard, which is based on the mission statement of the Heidelberg University Hospital.


paedKliPS offers specialized structures for the standardization of sample collection and the quantification of effects. This ensures the safety of study participants continuously while complying with all ethical and legal frameworks (Declaration of Helsinki, Good Clinical Practice [GCP]) and enables collection of valid and reproducible data of the highest quality.
You can download our ISO certificates here:
ISO-Zertifikat Deutsch 
ISO-Zertifikat Englisch