About us
About us
KCRI boasts over 18 years
of field-tested effectiveness
in clinical research
Portfolio
KCRI, which was founded in Krakow by a group of university physicians, is a full-service clinical research and education organization that serves the Sponsors as a gateway to a comprehensive portfolio of:
- 01. Study design, development and execution via its ISO-certified clinical research department, core laboratories and data management/bio statistics division
- 02. Regulatory support
- 03. Physician expertise both for trial-specific needs and product development
- 04. Customized problem solving and remediation/recovery of problematic studies
- 05. Education of health care and research professionals
KCRI manages around 60 long-term clinical projects per year and conducts daily operations in 20+ countries.
Team
Network
KCRI is a nimble and versatile research organization that has developed a network of partners, representatives and cooperating institutions worldwide. Majority of our operations cover European Union countries, but We are able to immediately utilize our connections for study and research purposes as well as expert consensus.
KCRI operates mostly in EU countries and SW with current research activities
Other countries with current or previous operational activities
Other EU countries covered in previous projects
Why KCRI
ISO-certified
Complete spectrum of services in clinical research certified with ISO 9001 and IEC/ISO 27001
Expert team
Highly qualified Team of MDs, PhDs, Engineers, MBAs and JDs
Medical devices experts
Unique expertise in the research of class III medical devices and implants
Cooperation with universities
Strong ties to local universities and scientists
Physician support
Physician expertise and support for trial-specific needs, product development and business development
Project Savers
Experience with remediation and recovery of problematic projects
Core Laboratory
We offer unique in-house Core Laboratory services
Start ups
We can boast extensive xperience 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.
