About us

Founded in 2004, KCRI has over 20 years of experience delivering high-quality, regulatory-ready clinical data.

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Portfolio

Founded in Krakow by a group of university physicians, KCRI is a specialized, full-service clinical research organization (CRO) supporting global clinical development programs for medical devices.

KCRI provides integrated support across the clinical study lifecycle, including:

  • 01. Study design and execution, including start-up, site activation and monitoring, supported by ISO-certified clinical operations, Core Laboratory and data management/biostatistics teams
  • 02. Regulatory support aligned with EU MDR, FDA expectations and global development requirements.
  • 03. Medical and physician expertise supporting study design, clinical execution and endpoint evaluation
  • 04. Support for recovery and optimization of complex clinical studies
  • 05. Training and education supporting clinical research quality and compliance
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KCRI manages around 60 long-term global clinical projects per year and conducts daily operations in 20+ countries.

Team

Łukasz Partyka Chief Executive Officer
Agnieszka Górowska Chief Operating Officer and General Counsel
Beata Chęcińska-Tokarz Chief Executive Clinical Operations Officer
Bartosz Daniszewski Chief Clinical Operations Officer
Wojciech Zasada Chief Medical Officer, Chief Core Laboratory Officer
Agnieszka Ćwiek Chief Clinical Operations Officer
Krzysztof Plens Chief Data Management Officer
Lidia Kabat Chief Safety Officer
Lidia Strzyż-Baydak Chief Quality & Regulatory Compliance Officer
Olga Gorodecka Chief Administrative Officer

Network

KCRI operates through a global network of partners, representatives and collaborating institutions.
This enables rapid access to sites, experts and research capabilities across multiple countries.

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 collaboration with academic institutions and scientific experts (worldwide)

Physician support

Medical expertise supporting clinical development, study design and evidence generation for medical technologies

Project Savers

Experience with remediation and recovery of problematic projects

Core Laboratory

In-house Core Laboratory integrated with clinical, regulatory and statistical expertise.

Start ups

We boast extensive experience with start-up companies

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