Core Laboratory services

KCRI is a full-service clinical research and education organization that serves the Sponsors as a gateway to a comprehensive portfolio of

• Trial design, setup and launch
• First In Man studies
• Study conduct and monitoring
• Safety assessment, coding and reporting
• Data management and biostatistics
• Data interpretation and expert guidance
• Study reports and publications
• Core laboratory services
• Regulatory affairs and consulting
• Data Monitoring Committees (DSMB and CEC)
• Key Opinion Leadership expertise

KCRI’s Core Laboratory offers independent, standardized and adjudicated data analysis of several imaging study endpoints:

  • Coronary and Peripheral
  • Intravascular Ultrasound (IVUS)
  • Virtual Histology (VH)
  • Optical Coherence Tomography (OCT)
  • Cardiac Magnetic Resonance (CMR)
  • Computed Tomography (CT)
  • Echocardiography (Cardiac ultrasound)

In addition, the Core Laboratory also provides independent, standardized and adjudicated analysis of trial Electrocardiograms (ECG).

The infrastructure of the Core Laboratory includes state-of-the art and validated analytical workstations with dedicated tools for quantitative data assessment and raw data management. The analytical plans are prepared in collaboration with the study leadership and the Data Management&Biostatistics department. The staff consists of dedicated analysts working under supervision of an internationally trained and experienced Director holding a PhD degree in Bioengineering.

KCRI is ISO 9001:2015 certified and ISO 14155: 2020 compliant
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Projekt strony dofinansowany z Funduszy Europejskich Inteligentny Rozwój