Trusted for safety  Chosen for speed  Recognized for quality  Advancing Early Phase  Clinical Research in Europe

About Biokinetica

Early Phase Clinical Reaserch Leader

Biokinetica is a specialized early‑phase clinical research unit supporting CROs, biotech, and pharmaceutical companies with high‑quality, hospital‑based clinical execution.
 
We are recognized for our commitment to safety, rapid participant recruitment, and flexible, tailor‑made study solutions that keep early‑phase development moving.
 
With an operational hub at the Academic Hospital Groningen in the Netherlands and an FDA‑inspected, state‑of‑the‑art Phase 1 Unit in the Warsaw area, Poland, we deliver reliable early‑phase studies with a strong focus on oncology, cardiovascular, and immunology.
 
Trusted for safety, choosen for speed, recognized for quality. 
 

State of the art Phase 1 unit

50-bed subject accommodation

24/7 medical coverage

Bio-storage room with -80°C freezers

Emergency ICU with direct Cardiac ECU access

Ambulatory Examination Rooms

Advanced medical equipment with full emergency response capabilities

In-house pharmacy

Modern surgical suite (full anesthesia & in-house CSF sampling)

In-house sample processing laboratory

Real-time cardiac safety monitoring system (QTc accredited)

High-Capacity Outpatient Screening Center

300 m² outpatient clinical facility in Warsaw, located near a major metro station

Dedicated on-site Sample Processing Laboratory

Seven general and specialized medical offices, including ultrasound and gynecology suites

Professional reception area with comfortable waiting space

Our Team

Biokinetica’s team of highly qualified professionals includes:
  • Board-Certified Investigators
  • Registered Nurses
  • Laboratory Diagnosticians and Technicians
  • Board-Certified Pharmacists
  • Project Managers and Study Coordinators
  • Dedicated Recruitment Team
  • Quality Assurance and Quality Control Specialists
 
We bring extensive experience in early phase trials across healthy volunteers and patient populations, ensuring scientific rigor and operational excellence at every stage.

Early-Phase Research Capabilities

by Type of Study

  • First-in-Human (FIH)
  • Biosimilars
  • Dose Escalation (SAD/MAD)
  • Pharmacokinetics/ Pharmacodynamics (PK/PD)
  • Proof of Concept (PoC)
  • Drug-Drug Interaction
  • Food Effect
  • Special Populations (Renal Impairment, Hepatic Impairment)
  • Thorough QTc and QTc modelling
  • CSF sampling

by Therapeutic Area

  • Oncology
  • Cardiology
  • Immunology
  • Neurology & CNS
  • Respiratory & Pulmonology
  • Gastroenterology
  • Metabolic Disorders
  • Infectious Diseases & Virology
  • Women’s Health

Our Approach to Early Phase Excellence

Flexible Collaboration for Long Term Partnerships

We tailor our collaboration models to the unique needs of every early phase program.
Whether partnering with your selected CRO or leveraging our complementary CRO services, the focus remains on building long-term relationships and becoming a trusted partner for your early-phase clinical studies.

Scientific Ethical
Excellence

Our medical and scientific teams strengthen development strategies through innovative study designs and early proof of concept endpoints. Participant safety and ethical conduct guide every decision we make.

Swift and Effective Recruitment

We deliver measurable value to sponsors and CRO partners through high-performance recruitment strategies. We swiftly and cost-effectively deliver large-cohort biosimilar studies, supporting global regulatory approvals and accelerating early market access.

Global Partnerships

We collaborate with leading global CROs, enhancing their portfolios with a high quality EU based Phase 1 unit recognized for fast recruitment and operational excellence.

News

Biokinetica By Numbers

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Clinics – Phase 1 Unit and Satellite Screening Clinic
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Operational Hubs, Phase I clinic and additional offices in the Netherlands
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Average annual increase of healthy volunteers in our database over the last 3 years
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Healthy Volunteers and Patients contacted over the last 2 years
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Largest Biosimilar Study conducted with Healthy Volunteers
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Healthy Volunteers enrolled in 1 month in a Single Biosimilar Study

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