We provide tailored early‑phase clinical solutions built around each client’s scientific, regulatory, and operational needs. Our dual‑country operating model accelerates regulatory pathways and ensures efficient, high‑quality study execution from the start.
By combining an FDA‑inspected Phase 1 Unit in the Warsaw area with an operational hub at the Academic Hospital Groningen in the Netherlands, we offer flexible, scalable, and regulatory‑aligned options for early‑phase studies. This structure enables fast recruitment, robust clinical delivery, and reliable early‑phase development across a wide range of study designs.
First-in-Human studies are the foundation of early clinical development. At Biokinetica, FiH trials are conducted in a hospital-based Phase 1 unit with continuous medical oversight, ensuring maximum safety for study participants and reliable early clinical data.
We conduct Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies to evaluate safety, tolerability, and pharmacokinetics across increasing dose levels in study participants or patient populations, supporting early decision-making in drug development.
We offer comprehensive solutions for design and conduct Proof of Concept studies that assess early biological activity and preliminary efficacy in patients, generating critical data for go/no-go decisions in early-phase clinical development.
Our pharmacokinetic (PK) and pharmacodynamic (PD) studies provide detailed insights into drug absorption, distribution, metabolism, excretion, and biological effects, supporting dose selection and regulatory submissions.
We conduct QTc studies in a certified Phase 1 environment, evaluating cardiac safety profiles using standardized ECG collection and analysis aligned with regulatory requirements.
We provide DDI studies to assess how investigational products interact with other medications, focusing on safety, tolerability, and pharmacokinetic impact, supporting regulatory expectations in early-phase development.
Our unit provides cerebrospinal fluid (CSF) sampling capabilities, enabling advanced CNS drug development through analysis of drug penetration, biomarkers, and PK/PD relationships.
We conduct early-phase clinical trials in patient populations and special groups, including elderly participants and those with renal or hepatic impairment, generating essential data for dosing strategies and safety evaluation.
