Trusted for safety Chosen for speed Recognized for quality Advancing Early Phase Clinical Research in Europe
Trusted for safety, chosen for speed, recognized for quality.
Biokinetica is a hospital-based early-phase clinical research unit in Europe, specializing in Phase 1 and First-in-Human clinical trials for pharmaceutical, biotech, and clinical research organizations. Operating within a fully integrated hospital environment, we combine clinical medicine with structured early-phase research execution to ensure the highest standards of safety, precision, and high-quality clinical data generation.
With an FDA-inspected Phase 1 unit near Warsaw, Poland, and operational facilities at the Academic Hospital Groningen in the Netherlands, we conduct reliable early-phase clinical trials across key therapeutic areas, including oncology, cardiovascular diseases, and immunology, as well as biosimilar clinical development programs. Our infrastructure supports both healthy volunteer and patient-based research in a controlled hospital environment.
Because we care.
Our mission is to accelerate early drug development by providing a safe, scientifically rigorous, and hospital-integrated environment for Phase 1 and First-in-Human clinical trials. We support biotech, pharmaceutical companies, and CRO partners as a long-term collaborator in early-phase clinical development, combining clinical expertise, operational strength, and strong ethical standards.
We are committed to improving the efficiency and quality of early-phase clinical trials in Europe while maintaining the highest standards of patient safety, scientific integrity, and regulatory compliance, ensuring reliable and high-quality clinical data in every study.
We tailor our collaboration model to each early-phase program, working directly with sponsors and alongside CRO partners. Our flexible approach supports Phase 1 and First-in-Human clinical trials across therapeutic areas, with a focus on long-term partnerships and efficient execution.
Our medical and scientific teams support early-phase clinical development through robust study design, First-in-Human expertise, and early proof-of-concept strategies. All trials are conducted under strict ethical and regulatory standards within a hospital-based clinical environment, with study participant safety as the top priority.
We deliver fast, reliable recruitment of study participants through a high-performing system designed for early-phase and large-cohort studies. Our approach ensures predictable timelines, efficient study startup, and high-quality clinical data to support regulatory submissions and global approvals.
We collaborate with global CROs and sponsors to deliver high-quality Phase 1 clinical trials in Europe. Our hospital-based infrastructure, strong recruitment capacity, and proven regulatory compliance enable reliable execution of complex early-phase studies.
Recognized by the U.S. Food and Drug Administration for meeting global regulatory and quality standards in early‑phase research.
Active participant in the international community dedicated to advancing clinical research site performance, quality, and collaboration.
Engaged in the European network for exploratory medicines development, reinforcing our commitment to scientific excellence and early‑phase innovation.
Operating under EMA and national regulatory frameworks to ensure the highest standards of safety, ethics, and data integrity.
Biokinetica is a family‑owned clinical unit, built on continuity, trust, and long‑term commitment to early phase research. This structure gives sponsors something rare in clinical development: a stable team, consistent oversight, and a shared sense of responsibility that spans generations.
Our family ownership is not just part of our history — it’s part of the reliability and care we bring to every study.
Seasoned entrepreneur and leader in the clinical research field. Founded Biokinetica in 2015 to meet the growing need for high‑quality early‑phase studies , and has since built the company into one of Europe’s leading early‑phase units. Actively contributes to shaping the clinical research landscape in Poland.
Over 30 years of clinical practice and more than 25 years in clinical research, with deep expertise across early‑ and late‑phase development. Served as Principal Investigator in nearly 200 Phase I–III trials, including multiple biosimilar programs. Her track record is consistently confirmed through successful audits and FDA inspections.
Recognized expert in early-phase clinical development with over 25 years of experience and management of 100+ early-phase projects. Works closely with sponsors to optimize study design and execution, and actively contributes to industry initiatives advancing best practices in clinical development.
Responsible for overseeing early‑phase projects with a strong focus on study‑subject recruitment and retention. Ensures each project begins with a thorough, data‑driven feasibility assessment and has a proven track record of delivering effective recruitment strategies across early‑phase studies.
