:quality(70))
MTZ Clinical Research powered by Pratia is a dedicated clinical research site in Warsaw, Poland, with extensive experience in healthy volunteer and early-phase studies, including bioequivalence, Proof-of-Concept, PK/PD, SAD and MAD studies, special populations and tobacco risk evaluation.
The site also supports Phase II–III clinical studies across a broad range of therapeutic areas, combining experienced research teams with dedicated clinical, pharmacy and laboratory infrastructure.
:quality(70)){kind=logo}
MTZ Clinical Research provides clinical research support across strategy, study execution, regulatory activities, data management and pharmacokinetics, with a strong focus on early-phase and specialized clinical research.
Support for early clinical development, including First-in-Human, SAD, MAD and PK/PD studies.
Experience in bioequivalence, bioavailability and biosimilar research involving healthy volunteers and patients.
Clinical research capabilities covering Proof-of-Concept, food-effect and Drug-Drug Interaction studies.
Experience with selected populations, including healthy male and female volunteers, participants with hepatic impairment and smokers.
Experience in conducting Phase I, II and III clinical trials across a range of therapeutic areas.
MTZ Pratia can support studies in the vast majority of therapeutic areas with over 85% of all indications covered, including:
Oncology
Hematooncology
Cardiovascular
Nephrology
Dermatology
Rheumatology
Vaccines
Gastrology
Urology
Pulmonology
Hematology
Metabolic diseases
Pediatrics
Diabetology
Surgery
Orthopedics
Neurology
Neonatology
Endocrinology
Allergology
Radiology
Immunology
Pain treatment
Gynecology
Laryngology
Technology
Psychiatry
Sleep disorders
Medical devices
Hepatic impairment
MTZ operates from a 2,000 sq. m. registered hospital facility in Warsaw, bringing together clinical research space, overnight capacity, a Hospital Pharmacy and a Medical Analysis Laboratory within one research environment.
The facility includes equipment and capabilities such as:
spirometry and ultrasound;
infusion pumps;
12-lead ECG machines;
IMP storage refrigerators;
-20°C and -70°C freezers;
refrigerated centrifuges for sample processing;
spectrophotometry;
access to dry ice;
dedicated facilities supporting smoking-related studies.
Our comprehensive clinical analysis capabilities:
four automated analyzers, including the advanced Roche Cobas 8000 system;
testing of liver function, creatinine, biochemistry, and electrolytes;
dedicated hematology analyzers for reliable blood parameter analysis;
microscopic and physicochemical urine testing.
:quality(70))
:quality(70))
:quality(70))
:quality(70))
MTZ has extensive experience in clinical trials involving nicotine products and tobacco risk evaluation. Dedicated facilities and an experienced research team support the specific operational requirements of these studies. The site's capabilities include research on:
:quality(70))
Our research experience is reflected in the number:
7,500+ randomized volunteers
480+ studies conducted
74 audits
12,000 volunteers in database
:quality(70))
MTZ's dedicated research team combines investigators, medical professionals, research nurses, coordinators and pharmacists required to conduct complex clinical studies. The team includes:
15 Principal Investigators
20 experienced Sub-Investigators
30 Research Nurses
12 Study Coordinators
3 Pharmacists
:quality(70))
:quality(70))
Quality Management
Our Quality Management System is based on:
Polish and EU legal requirements;
current GCP requirements;
applicable EU standards;
ISO 9001:2015.
MTZ first obtained ISO 9001 certification in 2009. The current certification confirms compliance with ISO 9001:2015 and covers contracted clinical trial activities as well as laboratory diagnostic services provided within MTZ Clinical Research powered by Pratia.
Inspections & Audits
MTZ has extensive experience with external oversight and quality review.
In recent years, the site has undergone:
2 FDA routine regulatory inspections;
2 Polish routine regulatory inspections;
25 audits conducted before, during and after clinical studies.
The inspections included review of bioequivalence and Phase III study conduct and confirmed compliance with GCP, local regulations and study protocols.
GCP Training & Accreditation
MTZ implements the ICH E6 Good Clinical Practice for Investigators and Site Personnel training program for its employees.
The program is accredited by GCPpi and TransCelerate BioPharma Inc.
Information Security
MTZ applies security procedures aligned with PN ISO/IEC 27001 requirements and internal company policies.
Industry Engagement
MTZ Clinical Research powered by Pratia is a member of the Society of Clinical Research Sites (SCRS), the global organization representing clinical research site interests.
:quality(70))
Reach out to schedule a meeting
Are you planning an early-phase clinical trial or looking for a trusted partner for studies involving healthy volunteers and special populations? Get in touch to explore how we can help you successfully deliver your next study.
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))
:quality(70))