The Polish National Node, represented by the Children’s Memorial Health Institute (IPCZD), a leading paediatric research hospital, supports the full lifecycle of paediatric clinical and translational studies through a CRO-like ecosystem integrating clinical research, laboratory services, digital medicine, biobanking, and regulatory support, combining clinical excellence, advanced laboratory capabilities, digital innovation, and regulatory expertise to accelerate paediatric translational research and precision medicine in Europe.
IPCZD provides comprehensive clinical trial services, including protocol development, regulatory strategy, CTIS and ethics submissions, site management, monitoring, pharmacovigilance, and project coordination, fully compliant with GCP, GDPR, ISO standards, and EU regulatory requirements. A key asset is access to a large and well-characterised paediatric population in Poland, enabling efficient recruitment, feasibility assessments, cohort identification, and long-term follow-up across multiple therapeutic areas, including rare diseases. IPCZD delivers advanced bioanalytical and translational services, including pharmacokinetics, toxicology, and therapeutic drug monitoring (TDM) using LC-MS/MS and complementary analytical platforms. Strong emphasis is placed on microsampling technologies (VAMS) to enable minimally invasive sampling in both preclinical and clinical paediatric studies, supporting precision dosing and high-quality regulatory data generation. IPCZD operates the PaedBioBank, providing high-quality biospecimen collection, processing, storage, and distribution under GDPR-compliant and FAIR data principles, supporting biomarker discovery and translational validation studies. Its digital research infrastructure enables integration of clinical, imaging, genetic, and molecular data within secure environments, supporting advanced analytics and precision medicine applications. Within digital health, IPCZD provides eConsent and ePROMS services, offering child- and caregiver-friendly digital tools for informed consent and patient-reported outcomes, with configurable platforms, usability-driven design, and iterative pilot testing for regulatory-compliant deployment. Additional capabilities include clinical validation of medical devices, feasibility studies, and EU grant support (e.g. Horizon Europe, IMI, EU4Health), delivered within a multidisciplinary, integrated research environment.