KCRI is a full-service clinical research and education organization

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About KCRI

KCRI was founded in Krakow, the educational and cultural heart of Poland, in 2004 by a group of university physicians. KCRI is a full-service clinical research and education organization that serves the Sponsors as a gateway to a comprehensive portfolio. KCRI manages around 60 long-term clinical projects per year and conducts daily operations in 20+ countries.

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Study design, development, execution, legal representation and regulatory support

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Grant activities

KCRI participates in variety of research activities founded by private and public grants. They include but are not limited to EU strategic initiatives, country-level projects, and manufacturer operated investigator initiated research programs

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Medical devices

Success in bringing a medical device to market is a sum of great idea, good engineering, proper investment process, regulatory awareness, clinical research, good timing, good research strategy, proper manufacturing.

Europe is an attractive place to start medical device development – convenient regulatory environment, cost-efficient clinical investigations, experienced and well-educated physicians

Quality

KCRI quality system is certified (EN-ISO-9001:2015)

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

Why KCRI?

Complete spectrum of services in clinical research (ISO-certified)

Highly qualified Team of MDs, PhDs, Engineers, MBAs and JDs

Unique expertise in the research of class III medical devices and implants

Strong ties to local universities and scientists

Physician expertise and support for trial-specific needs, product development and business development

Experience with remediation and recovery of problematic projects

Unique in-house Core Laboratory

Experience with start-up companies

Post-Market Clinical Follow-up (PMCF)

Post-Market Clinical Follow-up (PMCF) is the continuous process of active clinical data collection on the medical device safety and efficacy after market authorization.

PMCF is one of the essential regulatory requirements further emphasized and specified by Medical Device Regulation (MDR).

KCRI will help you collect and use these data for the life cycle management of your device. We developed an efficient and compliant data collection tool to help you in meeting CE (re) certification requirements. It is not only about the data collection, though. Our medical, regulatory, and statistical team will develop the entire PMCF strategy, following state-of-the-art methods and supporting you during the whole process.

KCRI is ISO 9001:2015 certified and ISO 14155: 2020 compliant
Website development project supported by European Funds Smart Growth
Projekt strony dofinansowany z Funduszy Europejskich Inteligentny Rozwój