Biokinetica | Biokinetica

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Who we are?

Biokinetica GmbH is a clinical research company equipped with its own Clinical Pharmacology Unit, headquartered in Berlin with an operational hub in Warsaw.

We specialize in conducting various Early Phase studies, including First in Human (FiH), Biosimilars, Proof of Concept, and other Clinical Pharmacology trials with Healthy Volunteers and Patients. Known globally, Biokinetica is recognized as an expert in conducting time- and cost-effective large Phase I Biosimilar projects with healthy volunteers.

As a reference Phase One Unit and preferred vendor, we are trusted by the world’s leading global CROs, and Pharma & Biotech companies.

Our clinical trials are conducted at our FDA-inspected, hospital-based, state-of-the-art Phase One Unit, located in the Warsaw area, Poland. The 50-bed hospital unit is located adjacent to a specialized cardiology hospital, a 5-minute drive from a general hospital, and 25 minutes from Warsaw Airport and downtown Warsaw.

Our Clinical Pharmacology Unit, spanning 1,500 sq.m, is comprehensively equipped and encompasses the following features

24/7 medical coverage

Bio-storage room equipped with -80°C freezers

In-house Emergency Intensive Care Facilities with direct access to a Cardiac ECU

Subject Accommodation with a Capacity of 50 Hospital Beds

Ambulatory Examination Rooms

Advanced Medical Equipment, including full-scale emergency response capabilities and more

On-site Pharmacy

On-premise Modern Surgical Suite for study procedures under full anesthesia

In-house Sample Processing Laboratory

Innovative Real-Time Cardiac Safety Monitoring System with cutting-edge technology, integrated with advanced analytics

Biokinetica’s Outpatient Satellite Screening Facility

Due to its excellent location adjacent to the metro station and well-orchestrated organization,
the clinic boasts a throughput exceeding 150 volunteers screened daily, including over weekends.

Outpatient clinic in Warsaw covers an area of 300 sq.m

A Sample Processing Laboratory

A 7-room General and Specialized Medical Office, including ultrasound and gynecological facilities

Reception & Waiting Area

Our Team

With a cadre of over 70 highly qualified study staff, each boasting an average clinical trial experience of 5 years, we present a robust team comprising:

Investigators (Board Certified Specialists)
Nurses
Laboratory Diagnosticians & Technicians
Pharmacists (Board Certified)
Project Managers & Study Coordinators
Recruitment Team
Quality Assurance & Quality Control Teams

Our specialized teams are dedicated to conducting early-phase studies with both healthy volunteers and patient populations across a diverse range of therapeutic areas.

Experience

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)

by Therapeutic Area

Oncology
Cardiology
Neurology & Central Nervous System
Respiratory & Pulmonology
Immunology
Gastroenterology
Metabolic Disorders
Infectious Diseases & Virology
Women’s Health

Our Mission & Goals

Customized Business Models for Long term relationships

At Biokinetica, we understand that each client and project has unique needs and objectives. Our offer of unparalleled business flexibility is crafted to align with these objectives.
Our ambition is to establish and maintain long-term partnerships, aiming to be your preferred resource for your Early Phase Clinical Studies.
Whether you opt to collaborate with your selected qualified CRO or leverage our complementary partner CRO services, we are committed to building a long-lasting relationship that grows with your business needs.

Swift and Effective Recruitment

Biokinetica’s ambition is to create value for our clients and partner CROs. Through highly effective recruitment campaigns, we are capable of swiftly and cost-effectively delivering large cohort Biosimilar studies to support global regulatory approvals and early market access.
At Biokinetica we understand the importance of providing access to new, innovative, and cost-effective therapies for patients worldwide.

Scientific & Ethical Excellence

Our experienced medical and scientific team is eager to add value to our clients’ strategic development plans by implementing innovative designs and early PoC endpoints.
We are steadfast in upholding the highest standards of quality and ethics, with subject safety positioned as our foremost priority.

Global Partnerships

Biokinetica is proud to collaborate with the world’s premier CROs and add value to their portfolio of capabilities as a highly effective, high-quality EU-based Phase I unit.

News

September 4, 2024

20th Biosimilar Medicines Conference in Amsterdam

Biokinetica By Numbers

Clinics – Phase 1 Unit and Satellite Screening Clinic

Average annual increase of healthy volunteers in our database over the last 3 years

Healthy Volunteers and Patients contacted over the last 2 years

Largest Biosimilar Study conducted with Healthy Volunteers

Healthy Volunteers enrolled in 1 month in a Single Biosimilar Study

Who we are?