Quality

KCRI quality system is certified (EN-ISO-9001:2008)

Certification body / Registrar:  Det Norske Veritas

Risk Based Certification™

Scope of certification: Consultancy with respect to the selection of clinical trial centres, medical and regulatory issues and GCP (good clinical practice). Planning, management and supervision of phase I/„First In Man”-IV clinical trials.  Independent and standardized analyses of angiographic images, intravascular ultrasound and ECG