Meet Aleksander Kiecana MD, Deputy Chief Medical Officer
Aleksander is a driving force behind our early-phase projects. With a strong focus on study-subject recruitment and retention, he brings a data-driven mindset to every stage of project delivery. He ensures each study begins with a comprehensive feasibility assessment, setting a solid foundation for success. His ability to translate insights into effective recruitment strategies has […]
Join us at Biosimilar Medicines Conference by Medicines for Europe in Amsterdam, 7-8 May
We’re excited to share that we will be attending the Biosimilar Medicines Conference This year’s programme focuses on how strategic collaboration across stakeholders and regions can unlock the full potential of biosimilars and drive meaningful impact for patients and healthcare systems. The agenda will cover key topics such as market competition, access strategies, and regulatory […]
Meet our Chief Operating Officer – Agnieszka Kulesza
With over 25 years of experience across CRO and site operations, Agnieszka is a true early-phase clinical development expert. She has led 100+ early-phase projects, including First-in-Human studies—consistently transforming complex programs into predictable, high-quality delivery. She collaborates with sponsors to optimize early-phase study design and execution, driving consistency and operational excellence. Agnieszka is deeply committed […]
World Health Day: Together for Health. Stand with Science.
At Biokinetica, we believe every breakthrough in medicine starts with a strong and safe foundation. Early phase clinical trials are where innovation meets responsibility — and where the future of healthcare begins. 🧬 Early phase matters:This is where new therapies take their first step, guided by science and careful oversight. 🛡️ Safety comes first:The wellbeing […]
Confidence in Cardiac Safety for Early-Phase Studies
Cardiac safety plays a critical role in enabling confident, timely decisions in early-phase trials. At Biokinetica, we combine state of the art faciilities with complex Phase 1 capabilities, precise QTc analysis, and real-time oversight to deliver reliable, high-quality cardiac data. From centralized ECG monitoring to automated detection of early safety signals, we support faster, data-driven […]
Meet our Chief Medical Officer – Monika Tomaszewska-Kiecana MD
With over 30 years of clinical practice and 25+ years in clinical research, Monika brings exceptional expertise to early- and late-phase development. As Principal Investigator in ~200 Phase I–III trials — including numerous biosimilar programs — she has led complex studies across cardiology, oncology, and internal medicine, with a strong focus on patient safety, data […]
Stay Ready: Mastering FDA Inspections in Early Phase Research
FDA inspections in early phase units are often seen as high-pressure events — but they are, in fact, powerful opportunities. A clean outcome doesn’t just confirm compliance; it demonstrates operational excellence, strengthens sponsor confidence, and validates the quality behind your data. Following our earlier short overview, we’re now sharing a more detailed guide. It takes […]
Case Study: Rapid Screening. Real-Time Data. Reliable Delivery.
Phase 1 Biosimilar Study: These were just some of the challenges our team faced in a recent Phase 1 biosimilar study conducted across two continents. 🎯 Our approach was clear: act fast, stay coordinated, and monitor data in real time.Key operational focus: 🏆 The outcome? Fast screening, strong retention, and reliable study delivery — even […]
Biokinetica: Driving confident early‑phase development
🔎 Have a look at our recent Biokinetica Early Phase Institute brochure, which outlines how we support pharma, biotech, and CRO partners with high‑precision early‑phase clinical research. 🌟 Our main qualities:• Hospital‑based, FDA‑inspected Phase 1 Unit ensuring high safety standards and uninterrupted study execution• High‑volume recruitment, with 150+ study participants screened weekly• Proven quality, including 2 FDA inspections across 3 […]
Patients Safety Awareness Week: “Team Up for Patient Safety”
This week, we recognize World Patient Safety Awareness Week — a time to reaffirm our commitment to protecting patients in every healthcare and research setting. At Biokinetica, study participants safety is the foundation of every early-phase study we conduct. Our dedicated medical team delivers patient-centered care supported by a robust quality framework and FDA-level compliance. […]
